Nasal drug delivery device and method of making same

ABSTRACT

A drug delivery device capable of forming a medicated mist that reaches the nasal and paranasal sinus cavities contains a puncturing element within its canister. The puncturing element is used in combination with a compartment that contains a filling. The compartment is optionally detachable from an interior of the device or entirely separate from the device. The puncturing element punctures the compartment, releasing the filling into the reservoir of the device to provide a medicated liquid. The device may store any form of medication so long as the medication remains stable. When dry powder forms are desired, the reservoir and/or compartment may be filled with a solution or diluent so as to form the medicated liquid, which may then be dispensed as a mist through the device following the puncturing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/263,233, filed Sep. 12, 2016, now U.S. Pat. No. 10,682,331, which isa continuation-in-part of U.S. application Ser. No. 15/225,465 filedAug. 1, 2016, abandoned, which is a continuation-in-part of U.S.application Ser. No. 14/295,502, filed Jun. 4, 2014, abandoned, which isa continuation-in-part of U.S. application Ser. No. 13/404,623, filedFeb. 24, 2012, now U.S. Pat. No. 9,440,020, wherein all of theabove-mentioned applications are hereby incorporated herein byreference.

TECHNICAL FIELD

The present invention generally relates to devices for administeringmedicated fluids to the upper airway in mist or droplet form.

BACKGROUND OF THE INVENTION

Devices used for administering liquid medication to a patient by way ofmist or liquid droplets are generally called nebulizers and areprimarily used for the delivery of medication into the lungs or lowerairways. These devices are best suited for the inhalation of the mist oraerosol through the patient's mouth or nose. This is accomplished bycreating an aerosol of small droplets or particles of 3-5 microns indiameter, and holding the resultant aerosol in a reservoir. The aerosolis then inhaled and the droplets are drawn into the lungs on the inhaledairstream. Aerosol droplets or particles are therefore so small andlightweight that, for the most part, they bypass the mouth, nose andthroat, leaving very little, if any, of the aerosol deposited in thenasal cavity. However, some cases require the introduction of liquiddroplets to the patient's nasal passages.

Current nasal drug delivery devices require medications to be deliveryin a separate container such as an ampoule or capsule, which requiresadditional handling steps by the user. In the case of medicated powders,for example, additional preparation must be performed to form asolution. These preparation steps may result in contamination, spillage,incorrect dosage dispensing, or misplacement. Shelf life, sterility, andstability of certain drugs is also shortened when drugs are delivered asa fluid to a patient. For example, some medications require cold storagethroughout their life cycle.

SUMMARY OF THE INVENTION

There is a need for a drug delivery device that provides ease of use andaccurate dosage in a quick step. There is further a need for a devicecapable of storing liquids and/or powders to alleviate the problemscaused by additional handling of certain medications by a user. Thedevice should be simple and minimize handling while alleviating theproblems of shortened shelf-life. These benefits, among others, areprovided by the improvements described herein.

Below is a simplified summary of this disclosure meant to provide abasic understanding of some aspects of the products and methodsdescribed herein. This is not an exhaustive overview and is not intendedto identify key or critical elements or to delineate the scope of thedescription. Its sole purpose is to present some concepts in asimplified form as a prelude to the more detailed description below.

Provided herein is a nasal drug delivery device comprising a canistercomprising a reservoir, an air exit port and a puncturing element on aninner surface of the canister, the air exit port extending beyond a rimof the canister and the puncturing element comprising a puncturing tipbelow the rim; an insert comprising a fluid channel that fits over theair exit port, and a pressurized air supply source for introducingpressurized air through the air exit port to dispense a medicationwithin the reservoir in the form of a mist. In one embodiment, the nasaldrug delivery device comprises an extension between the fluid channeland the canister, and a storage compartment comprising filling, thestorage compartment attached to the extension and the extensioncomprising an air vent to release air from the storage compartment,wherein at least a portion of the storage compartment is formed of amaterial that can be penetrated by the puncturing element to release afilling into the canister to provide for a medication to be dispensedthrough an exit hole of the fluid channel directly to a user. That is,the medication or medicated liquid is dispensed as a mist withoutpassing through any intervening structures or components. In oneembodiment, the medication within the reservoir is derived at least inpart from a separate, detached storage compartment, said detachedstorage compartment pierceable by the puncturing tip to provide for thefilling of the reservoir with the medication due to piercing. In any ofthe above embodiments, the reservoir comprises a powder. In someembodiments wherein the reservoir comprises a powder, the storagecompartment comprises a liquid capable of substantially dissolving thepowder. In any of the above embodiments, the filling comprises a liquid.In any of the above embodiments comprising an extension, the storagecompartment is permanently attached to the extension. In any of theabove embodiments, the storage compartment is optionally detachable. Inany of the above embodiments, the storage compartment comprises anaccessible filling port. In some embodiments, the storage compartmentcomprises a hermetic seal. In any of the above embodiments, the canisterand the insert are sealed together.

In any of the above embodiments, the nasal drug delivery device maycomprise more than one storage compartment. In any of the aboveembodiments, the nasal drug delivery device may comprise more than onepuncturing element.

In any of the above embodiments, the fluid channel fits over the airexit port to provide a small space between an outer surface of the airexit port and an inner surface of the fluid channel. In any of the aboveembodiments, the fluid channel comprises a groove extending verticallyalong the exterior of the fluid channel to an aperture in the extension,the aperture creating a channel to the reservoir of the canister.

A wide number of medications for the device described herein may be usedto reach the nasal and paranasal cavities, including dry forms such aspowders, liquid forms, and/or medications that require dilution, asfurther described below.

Other aspects, embodiments and features of the invention will becomeapparent from the following detailed description of the invention whenconsidered in conjunction with the accompanying drawings. Theaccompanying drawings are schematic and not intended to be drawn toscale. In the figures, each identical or substantially similar componentthat is illustrated in various figures is represented by a singlenumeral or notation. For purposes of clarity, not every component islabeled in every figure. Nor is every component of each embodiment ofthe invention shown where illustration is not necessary to allow thoseof ordinary skill in the art to understand the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features believed characteristic of the invention are setforth in the appended claims. The invention itself, however, as well asmode of use and advantages thereof, will best be understood by referenceto the following detailed description of illustrative embodiments whenread in conjunction with the accompanying drawings, wherein:

FIG. 1 is an exploded view of a nasal irrigator in accordance with anembodiment of the present invention;

FIG. 2 shows a cross sectional view of a canister in accordance with analternate embodiment of the invention;

FIG. 3 shows an alternate embodiment of the cover in accordance with thepresent invention;

FIG. 4 illustrates the use of the nasal irrigator of FIG. 1 inaccordance with an embodiment of the present invention;

FIG. 5 conceptually illustrates the function of the nasal valve inaerosol delivery that is initiated below the nasal valve;

FIG. 6 shows an embodiment of a nasal irrigator in accordance with anembodiment of the present invention;

FIG. 7 is a schematic cross sectional view of the assembled nasalirrigator of FIG. 6;

FIG. 8 shows a perspective view of an assembled nasal irrigator inaccordance with an embodiment of the present invention;

FIG. 9a shows an exploded view of an embodiment of a nasal irrigator inaccordance with an embodiment of the present invention.

FIG. 9b shows a bottom view of an insert in accordance with anembodiment of the present invention.

FIG. 10 shows a perspective view of an assembled nasal irrigator inaccordance with an embodiment of the present invention.

FIG. 11 is a schematic cross sectional view of the assembled nasalirrigator of FIG. 10;

FIG. 12a shows an exploded view of a nasal irrigator in accordance withan embodiment of the present invention.

FIG. 12b shows a bottom view of an insert in accordance with anembodiment of the present invention.

FIG. 13a shows a top perspective exploded view of the nasal irrigator ofFIG. 12.

FIG. 13b shows a cross-sectional side view of an assembled irrigator inaccordance with the present invention;

FIG. 14 shows a perspective view of an assembled nasal irrigator inaccordance with the present invention;

FIG. 15 shows an exploded view of a nasal irrigator in accordance withan embodiment of the present invention.

FIG. 16 shows a perspective view of an assembled nasal irrigator inaccordance with an embodiment of the present invention;

FIG. 17 shows a top view of the nasal irrigator of FIG. 16.

FIG. 18 shows a schematic cross sectional view of a filter in accordancewith an embodiment of the present invention.

FIG. 19A shows an exploded view of a portable irrigator according to anembodiment of the present invention.

FIG. 19B shows another perspective view of the portable irrigator shownin FIG. 19A.

FIG. 20 shows a front perspective view of an assembled portableirrigator as shown in FIGS. 19A and 19B.

FIG. 21A shows a perspective view of an assembled portable irrigatoraccording to an embodiment of the present invention.

FIG. 21B shows a perspective view of a portable irrigator as depicted inFIG. 21A.

FIG. 22 shows a cross sectional detailed view of a portion of the maincanister of an assembled portable irrigator according to an embodimentof the present invention.

FIG. 23 shows a perspective view of an assembled portable irrigatoraccording to an alternate embodiment of the present invention.

FIG. 24 shows an exploded view of another embodiment of a portableirrigator.

FIGS. 25A and 25B show a perspective view of a portable irrigator withthe canister attached to the pressurized air supply source.

FIG. 26A is a top view of the pressurized air supply source in oneembodiment.

FIG. 26B is a partial cross-sectional view of the canister attached tothe pressurized air supply source.

FIG. 27 shows a perspective view of a portable irrigator with the insertattached to the canister and pressurized air supply source.

FIG. 28 shows a cross-sectional view of the insert in one embodiment.

FIG. 29 depicts an assembled view of one embodiment of the portableirrigator with a cap over the insert.

FIG. 30 shows a side perspective view of a partial cross-section of thecanister attached to the pressurized air supply source.

FIG. 31 shows a view of the components within the pressurized air supplysource of a nasal irrigator in one embodiment

FIG. 32 shows a cross-sectional view of the nasal irrigator of FIG. 31.

FIG. 33A shows a partial view of one embodiment of the assembledirrigator with one side of the pressurized air supply source removed.

FIG. 33B shows a partial view of one embodiment of the assembledirrigator with the other side of the pressurized air supply sourceremoved.

FIG. 34A shows a perspective view of an inlet air manifold in oneembodiment.

FIG. 34B shows another perspective view of an inlet air manifold in oneembodiment.

FIG. 35 shows a perspective view of a filter cap of the portableirrigator in one embodiment.

FIG. 36 shows a block diagram of one embodiment of the programmablecircuit board.

FIG. 37 shows a cross section view of another embodiment of a canisterof an improved nasal drug delivery device.

FIG. 38 shows a cross section view of one embodiment of an insert of animproved nasal drug delivery device.

FIG. 39 shows a top view of one embodiment of an insert of an improvednasal drug delivery device.

FIG. 40 shows a cross section of one embodiment of an assembled improveddevice comprising an insert and canister.

FIG. 41 shows another embodiment of an assembled improved nasal drugdelivery system.

FIG. 42 shows another embodiment of an assembled improved nasal drugdelivery device.

DETAILED DESCRIPTION

The present invention improves upon current irrigator designs andprovides a method of delivering fluid to the nasal passages with littleinteraction required by the user, under sufficient pressure tostent-open the airway, and with particles of a size to ensure that themajority of the mist is retained or deposited within the upper airway.The invention also provides a nasal irrigator designed to deliver a mistto the upper airway through both nostrils simultaneously.

In one aspect, a nasal irrigator of the present invention comprises amain canister with a reservoir for holding fluid, wherein the canisterincludes at least two air exit ports; a removable insert with a circularbase that fits within said main canister, wherein the insert includes atleast two fluid channels that mate with said air exit ports of the maincanister, said fluid channels comprising two tubes ending in a commonbell housing above the base, wherein said base holds the insert just offof the main canister surface, allowing fluid to pass between the baseand main canister, and further wherein the fluid channels are larger indiameter than the air exit ports, thereby providing a small spacebetween the outer surface of the air exit ports and the inner surface ofthe fluid channels that allows fluid from said reservoir to be drawnupward between the air exit ports and fluid channels and expelled as amist in an aerosol plume through exit holes in the fluid channels due toa venturi effect created by pressurized air from the air exit ports; andat least one nozzle coupled to the bottom of said main canister tocreate at least one air chamber defined by the nozzle and said air exitports, wherein the nozzle includes an air inlet for providingpressurized air into said air chamber.

FIG. 1 is an exploded view of a nasal irrigator in accordance with anembodiment of the present invention. The nasal irrigation devicecomprises three major sections. The first major section is the maincanister 22 which has an expanded reservoir 10 that is capable ofholding up to 50 ml of fluid. The inner portion of the reservoir shapedat the bottom to ensure maximal uptake of fluid to reduce waste.

The main canister 22 also includes an air chamber 11 terminating in twoair exits 12 (one for each nostril) with holes sufficient to deliver anairstream that is able to atomize fluid and stent-open the upper airway.In one embodiment, each exit port 12 has at least one hole of between0.020″ and 0.060″ (0.508 mm-1.524 mm) in diameter and a web-thickness orhole length of between 0.030″ and 0.200″ (0.762 mm-5.08 mm).

On the bottom of the main canister 22 is a foot section 9 that includesone or more feet for stability and an air inlet 8 for the admission ofpressurized air to create the air stream through air exits 12. The footsection 9 enables the canister 22 to stand up when set on a horizontalsurface and is designed to fit into a standard docking port of an aircompressor pump to enable the device to remain upright in a hands-freemanner so as to remain filled with the air supply tube attached.

In the shown example, the main canister 22 has a two-step circumferenceto fit a holder (not shown) and provide adequate fluid volume for nasalirrigation, with the smaller diameter foot section 9 enabling the userto rest device in the holder with tube attached. In an alternateembodiment (not shown) the foot section 9 is wider than the reservoirsection 10.

The second major section of the irrigator is the insert 23, which isshown with a base 13 that holds the inside surface of the insert 23 justoff of the outer surface of the feature within reservoir 10 of the maincanister 22. At least one channel is located in the bottom of the insert23 to act as a conduit for fluid from the reservoir 10 to enter the baseof the insert. The insert 23 includes fluid channels 14 that mate withthe air exit ports 12 of the main canister 22. Peaks or extensions maybe included on the air exits 12 to ensure centering of the insert 23 andits fluid channels 14 on the air exits. Similarly, tabs may extend fromthe inside of the fluid channels of the insert to the outer surface ofthe main canister to ensure alignment. As shown, fluid channels 14 ofthe insert 23 comprise two tubes with one end at the bottom of thereservoir 10 and one end that is positioned in the airstream so that theairstream creates a negative pressure in each tube that draws fluid intothe airstream where it is atomized (described below).

In the embodiment shown in FIG. 1, the atomizer outlets 12, 14 extendabove the edge of the main canister 22. However, in an alternateembodiment (not shown) the atomizer nozzles are even with or recessedwithin the edge or portions of the edge of the main canister.

The insert 23 is keyed in at least one location with the reservoir 10 toensure that the insert does not rotate in relation to the exit ports 12of the main canister and to aid in centering of the insert 23 and itsfluid channels 14 on the air exits. The insert may include a feature toensure that it is inserted into the main canister in only oneorientation. In one embodiment, a loop (not shown) extends down to thesaddle of the insert 23 to hold down the insert.

The fluid channels 14 are slightly larger in diameter than the air exitports 12 of the main canister, thereby providing a small space(preferably 0.0001″ to 0.010″ (0.00254-0.254 mm)) between the outersurface of the air exit ports and the inner surface of the fluidchannels. This space allows fluid from the reservoir 10 to proceedupward between the air exit ports 12 and the fluid channels 14 untilbeing expelled by pressurized air. When the insert 23 is installed inthe main canister 22, the orifices of the fluid channels 14 arepositioned relative to the air exits 12 so as to create a venturi effectwith the pressurized gas expelled from the gas tubes. Because the fluidexits 14 in the insert 23 are larger than the air exits 12, when air isforced through the air exits at an appropriate volume and speed, fluidin the reservoir 10 is drawn up into the space between the insert andair exits ports. When this fluid meets the subsequent airstream it isatomized into particles conducive to deposition in the upper airway. Theairstream is sufficient to penetrate the nasal cavity above the inferiorturbinate so as to deposit the fluid and provide a washing, irrigation,or deposition to the upper reaches the nasal cavity.

The exit holes of the fluid channels 14 are small enough to ensure thatmist is created but large enough to ensure that the holes of the insertmay be chamfered so that the walls of the exit holes are angled awayfrom a central axis at an angle that exceeds the cone of the aerosolplume to reduce agglomeration of the mist particles upon exit, providinga more uniform particle size throughout the plume. The fluid channelsize may be adjusted to change the particle size of the mist. In oneembodiment the tubes have a mating section on the upper end that enablesthe changing of the orifice in the air stream via a series of nozzlesthat can be inserted into the upper end of the tubes such that the sizeof the nozzle orifice that is placed into the airstream is varied.

The third major section of the irrigator is nozzle cone 3. The nozzle 3includes an air inlet 6 and a mating surface 7, which attaches to theair inlet 8 of the main canister 22 to create air chamber 11 defined bythe nozzle and the two exit ports 12 described above. The length of allcomponents on the nozzle cone 3 preferably is limited so that the nozzlecone or its components do not extend past the foot section 9 on the maincanister 22 when the device is assembled to enable the device to beplaced on a flat surface in an upright or standing position.

Ribs may also be molded into the nozzle cone 3 to provide radialstiffness. In another embodiment, the nozzle cone is made of rigidplastic.

The mating surface between the nozzle 3 and main canister 22 is designedto ensure a tight bond can be created. In an alternate embodiment themating surface between the nozzle 3 and main canister 22 is essentiallystraight.

In one embodiment, the nozzle cone 3 is attached permanently to the maincanister 22. In an alternate embodiment, the nozzle cone 3 may utilize afriction fit or have a positive connection such as a thread or othermechanism allowing the nozzle cone and main canister 22 to bedisconnected for cleaning. This detachable embodiment may include an airseal such as an O-ring as well as a flange to grasp for easydisassembly.

An air supply tube 5 connects the air inlet 6 of the nozzle cone with anair supply 17.

FIG. 2 shows a cross section view of a canister 25 in accordance with analternate embodiment of the invention. In this embodiment, rather than asingle air chamber and nozzle, the canister 25 includes separate airpassage chambers 26 that terminate in the air exits 27. These separateair passage chambers 26 can connect to separate air sources via separatenozzles. Alternatively, the separate air passage chambers 26 can beconnected to a common air source via split tubing such as a Y or Tadapter (not shown).

In addition to the three major sections described above, the irrigatormay include a cover 4 that has a mating surface 15 that creates anisodiametric connection to the main canister 22. In the example shown inFIG. 1, the cover 4 is a broad cover region to block space between thenose, eyes and the rest of the face when in use as shown (see FIG. 4).In this embodiment the cover 4 is designed to confine the mist expelledfrom the fluid channels and shield the patient's eyes, with an openingto provide room for the patient's nose within the apparatus. The cover 4is radiused along the distal end away from the main canister 22 to fit abroad variety of faces and is open to enable air to enter as the fluidis drawn down and capture and recycle fluid that falls off the face.

The cover may also incorporate a cross member or other device thatretains the insert 23 to allow for clearance of the nose and preventlifting of the insert at the initiation of atomization. In oneembodiment a sleeve or partial sleeve extends from the cover 4 to thebase of the insert 23 to hold the insert down.

FIG. 3 shows an alternate embodiment of the cover in accordance with thepresent invention. In this embodiment, the cover 28 is a semi-circularlid that does not block the eyes but instead retains the insert andblocks material from re-entering the main canister from the nose.

The present invention may incorporate a feature that guides the user toangle the spray into the nose at a set angle from 0-90 degrees from theplane defined as the front of the face from the chin to the forehead(i.e. the vertical plane of the face). For example, the irrigator mayinclude a setoff designed to set a specific angle of 30 degrees, 45degrees, or 60 degrees from the vertical plane of the face. The setoffmay be removable for various size faces or noses.

Materials suitable for construction of the irrigator include rigidplastic, glass, metal, ceramic, carbon fiber or other rigid material, oran elastomer plastic or some combination thereof.

One embodiment of the nasal irrigation device (not shown) is egg-shapedor ovoid for better fit into the hand and a pleasing look.

FIG. 4 illustrates the use of the nasal irrigator in accordance with thepresent invention. The irrigator is placed over the face of the user 18and angled such that the cover 4 blocks the eyes. The mist 20 enters thenasal passages 21, and the patient breathes through both the mouth andnose at the same time (24). The mist 20 passes into the nasal passages21 independent of the patient's breathing.

The air-fluid mixture is calibrated to achieve nasal irrigation within ashort period of time, without the need for the fluid to exit thenostrils at the time of irrigation, and with a particle size that isdesigned to loosen the mucous or to enter the sinus cavities, as desiredby the end user and not enter the pharynx or the lungs.

In one aspect, the method of nasal irrigation comprises providing fluidin a canister that includes at least two air exit ports mated tocorresponding fluid channels, wherein the fluid channels are larger indiameter than the air exit ports, thereby providing a small spacebetween the outer surface of the air exit ports and the inner surface ofthe fluid channels. This space allows fluid from said reservoir to bedrawn upward between the air exit ports and fluid channels. Pressurizedair is pumped through the air exit ports, thereby creating a venturieffect that draws fluid from said reservoir upward between the air exitports and fluid channels and expels the fluid as a mist in an aerosolplume through exit holes in the fluid channels and into a user's nasalcavity above the inferior nasal turbinate independent of the user'sbreathing. The pressurized air has a pressure of 0.069-1.035 bar and anairflow rate of 1-12 liters per minute, producing a fluid delivery rateof 1-20 ml per minute.

The method of nasal irrigation offers a fast, convenient method ofatomizing saline or medication for delivery to the nose, with a variableparticle size up to 100 microns. In one embodiment, particle size is atleast 10 microns.

Using an air pressure of 1-15 psi (0.069-1.035 bar) creates apressurized airflow that enables the resultant air-mist stream tostent-open the soft tissues of the upper airway. In one embodiment, theair pressure ranges from about 3-12 psi (0.207-0.823 bar), with about1-12 lpm of airflow, and a fluid delivery rate of about 1-20 ml perminute. In one embodiment, the air pressure ranges from about 4-8 psi(0.276-0.552 bar), with about 3.5-8 lpm airflow, and about 15 ml perminute fluid delivery.

The resultant mist reaches the area of the nasal cavity and paranasalsinuses above the inferior nasal turbinate or chonchae to ensure thatthe mist reaches the areas of the sinus ostia to clear this area of thenasal cavity and enable the natural mucociliary flow to clear thesinuses.

Recent medical research has noted that the olfactory and trigeminalnerves may be used as a pathway to deliver large and small molecules tothe brain and central nervous system that bypasses the blood brainbarrier and first pass metabolism of intravenous and oral deliveryroutes. (See Dhanda, D., Frey W H 2^(nd), Leopold, D., Kompella, U B:“Nose-to-brain delivery approaches for drug deposition in the humanolfactory epithelium.” Drug Delivery Technol. 5(4), 64-72 (2005).) Freyand others have demonstrated that these nerves may be reached via thenasal mucosa overlying the olfactory cleft and cribriform plate wherethese nerves are concentrated. Furthermore, the frequency of dosing ofmany of these materials requires a delivery system that is practical andeasy to use. In the case where systemic delivery of drugs via the noseis desired, maximizing the surface area of the mucosa covered by themedication may improve the amount of medication that is absorbed by thebody and may reduce the variability of absorption between doses andacross patients; thus improving the bioavailability of the drug andreducing the variability of bioavailability of the drug. Furthermore, bymaximizing the surface area available for absorption of any given drug,the concentration required to deliver an effective dose may be reducedwhen compared to traditional metered dose inhaler technology, enablingmore drugs to be delivered transnasally than with other systems.

However, the literature suggests that adequate delivery systems arelacking for the reliable and practical delivery of these substances tothese areas. Delivery of large particles (>10 microns) of liquids in thedescribed volumes as provided by the present invention, offersadvantages over dry powder, minute volumes and high volume solutions.These advantages include covering the whole nasal mucosa, formulatingdrugs for patient comfort vs. concentration, reducing the inadvertentdelivery of aerosolized materials to the lungs; and the ability todeliver precious materials economically and judiciously while reducingwaste.

In one aspect, the present invention provides a method of treatingneoplasms of the nasal cavity comprising fluid in a canister, whereinthe canister includes a reservoir and at least two air exit ports, andwherein said fluid contains corticosteroids. The air exit ports aremated to corresponding fluid channels, wherein the fluid channels arelarger in diameter than the air exit ports, thereby providing a spacebetween the outer surface of the air exit ports and the inner surface ofthe fluid channels, which allows fluid from said reservoir to be drawnupward between the air exit ports and fluid channels. Pressurized air ispumped through the air exit ports, thereby creating a venturi effectthat draws fluid from said reservoir upward between the air exit portsand fluid channels and expels the fluid as a mist in an aerosol plumethrough exit holes in the fluid channels and into a user's nasal cavityabove the inferior nasal turbinate independent of the user's breathing.

The present invention allows for delivering steroids for the long-termcontrol of benign neoplasms of the nasal cavity, such as inflammatorynasal polyps, granulomas, etc., without systemic doses of steroids orsteroid injections. It also provides the ability to irrigate the wholenasal mucosa to manage the disruption of natural filtering andhumidification often caused by ablative and reconstructive surgicaltreatment of neoplasms. Unlike prior art saline irrigation and nasalsprays which do not reach many of the areas of concern in the nasalvestibule and paranasal sinus areas, the irrigator of the presentinvention delivers adequate moisture in less than one minute to theareas of concern. The present invention also avoids pooling of moisturethat can otherwise provide a nidus for infection and cause excessiveremoval of the immunologic mucus blanket of the nose.

The high frequency of steroid administration needed to control neoplasmgrowth requires a delivery system that is practical and easy to use. Theirrigator of the present invention can deliver these steroids quickly—inless than one minute—covering the whole nasal cavity and does so withoutunduly exposing the body to the effects of systemic steroids.

For example, using the irrigator of the present invention, 0.60 mgs ofcorticosteroid is typically delivered to the nasal cavity, between twoand ten times the amount delivered via metered dose inhalers. In someinstances, antibiotics are delivered along with the corticosteroid totreat infections such as Staphylococcus aureus. Staph aureus endotoxinhas been shown to up-regulate the beta isoform of cortisol receptor(CR_(β)) in cell membranes that is responsible for inhibiting theresponse to corticosteroids, and it is believed that the Staph infectionmay contribute to steroid-resistant nasal polyps. The concurrentadministration of antibiotics with the corticosteroid via the irrigatorof the present invention reduces this endotoxin effect on the cortisolreceptor, thereby increasing the efficacy of the steroid therapy.

The pressure and airflow necessary to deliver material to the upperportion of the nose can be reduced if the aerosol is introduced distalof the nares at or above the nasal valve and proximal to the inferiorturbinate. The present invention delivers droplets or mists with an airstream and particle sizes designed to stay in the upper airway undersufficient pressure and airflow to overcome the normal aerodynamics ofthe nose. Unlike prior art methods, the present invention releases mistat or above the nasal valve, thereby avoiding deflection of the fluidoff the walls of the nostril and nasal valve.

Effective delivery of material to the nasal cavity requires a particlesize that is large enough to fall out of the airway before reaching theoropharynx, delivered under sufficient pressure and airflow to overcomethe aerodynamics of the nasal cavity. The nasal cavity is shaped toefficiently deliver air to the lungs. Air enters the nares and passesthrough the nasal valve, which resides approximately 1.3 cm above thenares and is the narrowest portion of the nose, with a cross-section ofat approximately 0.73 cm². The nasal valve is the narrowest anatomicportion of the upper airway, resulting in the volume of air inspirednasally to be efficiently cleansed and humidified by the nasal cavity.

FIG. 5 conceptually illustrates the function of the nasal valve inaerosol delivery that is initiated below the nasal valve. Arrows 120represent an aerosol flowing into the nasal nares. As illustrated byarrows 121, a portion of this aerosol is reflected off the walls of thenose as the passageway narrows to the nasal valve 130. This reflectedmaterial falls out of the nose and is either wasted or is recollected bythe device to be delivered repeatedly.

The nasal valve 130 acts to reduce the flow (F) and pressure (P) of thatportion of the aerosol stream that crosses the valve and enters thenasal cavity 110. Thus, Flow in (F_(I)) is greater than Flow out(F_(O)), and Pressure in (P_(I)) is greater than Pressure out (P_(O)).As a result, aerosol entering the nasal cavity external to the nasalvalve requires a higher pressure and flow rate to achieve the sameaerosol distribution as an aerosol introduced internal to the nasalvalve.

Air entering the nose meets additional resistance at the level of theinferior turbinate, which directs air downward along the floor of thenose along the path of least resistance. During inhalation, the airflowis dominated by the negative pressure being generated from the lowerairway and is directed to the nose from the pharynx. This negativepressure and the structure of the nasal cavity conspire to direct themajority of the air through the lower third of the nose, with verylittle air entering the upper portion of the nose. Indeed, studies haveshown that to reach the upper portion of the nose under the negativepressure of normal breathing, an aerosol must be placed very preciselyat the front of the nares. To overcome the aerodynamics of the nose, thedelivery system must provide a positive pressure and sufficient airflowto fill the whole nasal cavity.

Prior art devices that deliver aerosol below the nasal valve mustgenerate higher pressure and flow rates since the valve acts to lowerthe pressure and flow as the aerosol passes through it. The design ofthe present invention is directed to the self-administration of fluid tothe nasal passages of a patient while ensuring the device fits a widevariety of faces and for simplicity of design, ease of manufacturer. Itrequires lower pressure and airflow and produces less mess by virtue ofdelivery above the nasal valve, and simplicity of use, including shortdelivery times.

The invention delivers fluid to the nasal passages with littleinteraction required by the user and under sufficient pressure tostent-open the airway. The invention delivers particles of a size toensure that the majority of the mist is retained or deposited within theupper airway, while maximizing the amount of drug delivered andeliminating reflection back from the nasal valve.

FIG. 6 shows an embodiment of a nasal irrigator in accordance with thepresent invention. The nasal irrigator comprises three main components.The first component is the main canister 201, which has a fluidreservoir 202 and an air exit port 203 that extends above the reservoir.In one embodiment, the reservoir 202 holds up to 30 ml of fluid ormedication. As shown in FIG. 1, the lower portion of the reservoir isdownward sloping to ensure fluid collects at the bottom, which allowsmaximal uptake of fluid through fluid channels (explained below),thereby minimizing waste.

The air exit port 203 has at least one exit hole 204 at the topsufficient to deliver an airstream that is able to atomize fluid anddeliver the aerosol to the whole nasal cavity. In one embodiment, theexit hole 204 is between 0.020″ (0.508 mm) and 0.060″ (1.524 mm) indiameter and the air exit port has a web-thickness of between 0.030″ and0.200″ (0.762 mm-5.08 mm).

The main canister 201 also included an air inlet 205 on the bottom forthe admission of pressurized air to create the air stream exiting theair exit port 203.

In one embodiment, the main canister 201 has optional “feet” on thebottom (as shown in FIG. 1) for stability. The length of all componentson the nozzle cone is limited so that the nozzle cone or its componentsdo not extend past the feet on the main canister when the device isassembled to enable the device to be placed on a flat surface in anupright or standing position. The canister 201 may also be designed tofit into a standard docking port of an air compressor to enable thedevice to remain upright in a hands-free situation so as to be filledwith the air supply tube attached.

The second main component of the nasal irrigator is an insert 206 thatfits over the main canister's air exit port 203. The insert 206 can bepermanently attached to the canister 201 or it may be removable. Theinsert 206 has an aerosol exit 210 that is concentrically aligned withthe exit hole 204 of the air outlet 203. A peak or extension on the airexit port 203 may ensure centering of the insert over the air outlet.Similarly, tabs on the insert may be used to center the insert over theair outlet and prevent it from being moved by force. The aerosol exit210 is slightly larger than the exit hole 204 of the air exit port 203to enable atomization of fluid in the air stream.

The insert 206 has a tapered inner diameter 207 that is larger than andfollows the contours of the outer diameter 208 of the air exit port 203.This difference in diameter creates a space of between 0.0001″ (0.00254mm) and 0.010″ (0.254 mm) between the inner surface of the insert 206and the outer surface of the air exit port 203. This space allows fluidto be drawn from the reservoir 202 through a channel 209 at the basethat is sized to control the fluid flow.

The third main component of the nasal irrigator is the cover 211 thatmates with the reservoir 202 of the main canister 201 and extends overthe insert 206 such that the insert does not contact the nose as thedevice is inserted into the nasal cavity, thereby ensuring that the hole210 in the insert 206 and the hole 204 in the air exit port 203 remainconcentrically aligned. The cover 211 includes a mating surface 212 thatcreates a preferably isodiametric connection to the main canister 201and extends around the nozzle formed by the insert 206 and air exit port203. The cover 211 extends just above the insert 206 and has its ownexit hole 214 designed not to restrict the flow of the aerosol plume. Inone embodiment, the cover 211 provides a cross member or other featurethat secures the insert 206 to prevent lifting of the insert at theinitiation of atomization.

FIG. 7 is a schematic cross section view of the assembled nasalirrigator in accordance with the present invention. This view shows thealignment of the canister 201, insert 206, and cover 211 and theresulting fluid space 215. When fluid is in the reservoir 202 and apressurized air source is introduced to the system via air inlet 205, avacuum is created in the space 215 as air exits through outlets 204 and210. Because the aerosol exit hole 210 in the insert 206 is larger thanthe exit hole 204 of the air exit port 203, when air is forced throughthe air exit port 203 at an appropriate volume and speed it creates aventuri effect as the pressurized gas is expelled, thereby drawing fluidin the reservoir 202 up into the space 215 between the insert and airoutlet. When the fluid reaches the airstream between the exit holes 204,210, it is atomized in the airstream to create an aerosol. This aerosolis sufficiently dispersed within the nasal cavity above the inferiorturbinate so as to the reach the upper nasal cavity.

The aerosol exit 210 in the insert 206 is small enough to ensure that amist is created yet large enough to ensure that the hole can bechamfered on the outer side to reduce agglomeration of the mistparticles upon exit. The aerosol exit hole 210 is chamfered so that thewalls of the exit are angled away from a central axis of the hole suchthat the angle is greater than that of the aerosol plume. Thischamfering reduces agglomeration of particles on the walls of theaerosol exit hole 210, resulting in uniformity of particle size acrossthe resultant aerosol plume.

The base of the insert 206 sits in a groove 217 at the base of thecanister 201, ensuring that all fluid is drawn from the bottom of thecanister.

The irrigator components of the present invention can be made frommaterials such as rigid plastic, glass, metal, ceramic, carbon fiber orother rigid material, an elastomer plastic, or some combination thereof.

FIG. 8 shows a perspective view of an assembled nasal irrigator inaccordance with the present invention. By maintaining a sufficientlynarrow nozzle assembly 218, and a sufficiently long and smooth cover219, the device can be easily and atraumatically inserted into the noseof the patient so that the nozzle 218 extends to or above the nasalvalve. The device is then angled by the user to obtain the bestdistribution based on the user's anatomy. The mist enters the nasalcavity independent of the patient's breathing.

The nasal irrigator of the present invention may also include a featurethat guides the user to angle the spray into the nose to a set angle ofbetween 0 and 90 degrees from the vertical plane of the face (defined asthe front of the face from the chin to the forehead). For example, oneembodiment of the nasal irrigator includes a setoff that sets a specificangle of 30 degrees from the vertical plane of the face. In anotherembodiment, the setoff angle is 60 degrees from vertical, and in anotherembodiment the setoff angle is 45 degrees from vertical. The setoffdescribed above is removable to accommodate various size faces andnoses.

The method of nasal irrigation of the present invention uses a variableparticle size up to 100 microns under a pressure of 1-15 psi(0.069-1.0345 bar), creating a pressurized airflow that enables theresultant air-mist stream to reach the whole nasal cavity independent ofthe patient's breathing. The resultant aerosol mist reaches the area ofthe nasal cavity above the inferior nasal turbinate or chonchae toensure that the mist reaches the areas of the sinus ostia to clear thisarea of the nasal cavity and enable the natural mucociliary flow toclear the sinuses.

By adjusting the size of the exit holes 204 and 210, the air-fluidmixture can be calibrated to achieve nasal irrigation within a shortperiod of time, without the need for the fluid to exit the nostrils atthe time of irrigation, and with a particle size that is designed toloosen the mucous or to enter the sinus cavities, as desired by the enduser. In many applications, ideally a mist of 20 microns is delivered ata rate of 0.5 ml per second.

The aerosol mist itself is typically medicated with at least one, andoften two or more therapeutic agents. Possible therapeutic agents foruse in the medicated mist, either alone or in combination includeantibiotics, antifungal agents, corticosteroids and mucolytic agents.The mist may also be medicated with a neurologically-active agenttargeting the central nervous system through the cranial nervesinnervating at least a portion of the nasal cavity as well assystemically-active agents.

FIG. 9a is an exploded view of an improved nasal irrigator deviceaccording to one embodiment of the present invention. The devicecomprises a main canister 220, an insert 221, and a cap 223. The maincanister 220 and the insert 221 comprise many of the samecharacteristics of the irrigator described with relation to FIG. 1. Themain canister 220 comprises a rim surrounding a reservoir 227, which canhold up to 50 mL of fluid. While the reservoir is depicted assubstantially circular, it should be appreciated that the reservoir maycomprise any shape. In one embodiment, the reservoir comprises an ovalshape. As previously described with respect to FIG. 1, the main canister220 also comprises an air chamber that terminates into at least one airexit port 228. In one embodiment, as depicted in FIGS. 9-11, the airchamber of the canister terminates into two air exits ports 228 (one foreach nostril). In another embodiment, as best depicted in FIGS. 12-14,the air chamber of the canister terminates into only one single air exitport.

As described above with respect to FIG. 1, each air exit port 228 has atleast one hole of between 0.020″ and 0.060″ (0.508 mm-1.524 mm) indiameter and a web-thickness or hole length of between 0.030″ and 0.200″(0.762 mm-5.08 mm). In addition, as with the embodiment of FIG. 1, onthe bottom of the main canister 220 is a foot section 224 that includesat least one foot for stability and an air inlet (as depicted in FIG.11) for the admission of pressurized air to create the air streamthrough air exit ports 228. The foot section 224 enables the canister220 to remain standing on its own when set on a substantially horizontalsurface and is designed to fit into a standard docking port of an aircompressor pump to enable the device to remain upright in a hands-freemanner so as to remain filled with the air supply tube attached.

The insert 221 comprises a base 229 that fits within the canister 220and sits just off the bottom of the reservoir 227. In one embodiment, asdepicted in FIG. 9, the base 229 is circular. However, the base maycomprise any number of shapes so long as it fits within the canister.The insert 221 further comprises a fluid channel 225 that fits over theair exit port 228, said fluid channel 225 comprising a tube portionending in a common bell housing 234 above the base. In one embodiment,the insert comprises two fluid channels. In another embodiment,described below, the insert comprises one fluid channel.

As best depicted in FIG. 9 b, the bottom face of the base 229 of theinsert 221 comprises at least one groove 226 that forms a communicationchannel between the canister and the common bell housing of the insert.The groove 226 extends from the outside of the base to the inside of theinsert. The base should comprise at least one groove but may alsocomprise more than one, as depicted in FIG. 9b . The number of groovesas well as the width and depth of the groove will help regulate the flowof fluid up to the point that the airflow takes over the upper limit offlow. In one embodiment, the grooves may range in width from about0.005″ to about 0.150″ (0.127 mm to about 3.81 mm). In one embodiment,the grooves may range in depth from about 0.001″ to about 0.050″ (0.0254to about 1.27 mm). The fluid channel 225 is larger in diameter than theair exit port 228, thereby providing a small space between the outersurface of the air exit port 228 and the inner surface of the fluidchannel 225 that allows fluid from said reservoir 227 to be drawnthrough the communication channel and upward between the air exit port228 and the fluid channel 225 such that the fluid is expelled as a mistin an aerosol plume through an exit hole 230 in the fluid channel due toa venturi effect created by the introduction of pressurized air from theair exit port.

In one aspect, the canister 220 and the insert 221 are preferablyaffixed together such that the insert 221 and the canister 220 togetherform an integral piece. As used herein, “affix” relates to a secureattachment between the canister and insert and may include bothpermanent bonding and temporary bonding, which may only be subsequentlymanually separated. Preferably, the affixing of the insert and canisterwill not interfere with or negatively affect the communicationchannel(s) formed by the grooves in the bottom face of the insert. Inone embodiment, the insert 221 is permanently affixed or bonded to thecanister 220 at the bottom face of the insert. The bond may be formed byany means known in the art including without limitation use of a solventbond, glue UV-cured adhesives, mechanical attachment, heat forming, orradiofrequency or ultrasonic welding. In another embodiment, thecanister 220 and the insert 221 may mechanically mate together, such aswith a friction fit or a snap fit, to form a temporary connectionbetween them that can be subsequently separated by the user as desired.

In yet another embodiment, where the insert comprises two fluidchannels, the nasal irrigator may further comprise a cross bar component222 having an edge that fits around the rim of the canister. Thecrossbar component may comprise a single crossbar 232 that extends fromone edge of the component 222 to another edge, dividing the component222 into two substantially equal halves, as depicted in FIG. 9a forexample; or it may comprise a crossbar that extends from one edge to oneor more other edges at a different locations around the circumference,dividing the enclosed space into multiple areas. In such embodiments,the crossbar component 222 may be permanently affixed or bonded to therim of the canister 220, thereby affixing the insert 221 to the canister220. The bond may be formed by any means known in the art includingwithout limitation use of a solvent bond, glue UV-cured adhesives,mechanical attachment, heat forming, or radiofrequency or ultrasonicwelding.

Covering the canister 220, insert 221, and optional crossbar component222 is a cap 223 without holes therethrough. As depicted in FIG. 10, acap 223 fits over the rim of the canister 220 and covers the tubeportion of the insert, plugging the exit hole 230 of the fluid channel225 and the air exit port 228 to form an airtight, hermetic seal for theirrigator device, preventing the leakage of the fluid from thereservoir. The cap may further comprise an alignment feature or thumbhold 231 along its outer edge, which may align with a similar alignmentfeature or thumb hold on the exterior of the canister 220. Thus, theirrigator in one embodiment allows for sterile or non-sterile drugstorage and serves as a carrier for the transport or shipment ofmedication or irrigation fluid.

FIG. 11 is a cross sectional view of an assembled nasal irrigatorcomprising a canister 220, insert 221, optional crossbar component, andcap 223. As best shown here in FIG. 11, the cap 223 may comprise sealingplugs 233 recessed within the cap, which extend through both the exithole 230 of the fluid channel 225 and the air exit port 228. In oneembodiment, the sealing plugs 233 may be comprised of an expandablematerial, which will expand once removed from the top of the irrigatordevice. In another embodiment, the cap may be threaded and include agasket to form a compression seal. When ready for use, a user can removethe cap and connect an air supply to the air inlet beneath thereservoir.

A method of forming a disposable nasal irrigator in comprises the stepsof providing a canister 220 with an air exit port 228 and a rimsurrounding a reservoir 227 for holding fluid; providing an insert 221with a base 229 that fits within the canister 220, the insert 221comprising a fluid channel 225 that fits over the air exit port 228,said fluid channel comprising a tube portion ending in a common bellhousing 234 above the base, said base comprising at least one groove 226along its bottom face forming a communication channel between thereservoir 227 of the canister 220 and the common bell housing 234,wherein the fluid channel 225 is larger in diameter than the air exitport 228, thereby providing a small space between the outer surface ofthe air exit port 228 and the inner surface of the fluid channel 225that allows fluid from said reservoir 227 to be drawn through thecommunication channel and upward between the air exit port 228 and fluidchannel 225; and affixing the canister 220 together with the insert 221,thereby forming one integral structure.

The providing steps (a) and (b) can comprise the step of manufacturingthe canister or the insert, or both the canister and the insert. Themanufacturing can be performed by any means known in the art includingwithout limitation molding, forming, shaping or any combination thereof.The providing step (a) may also comprise the step of obtaining thecanister from any manufacturer or vendor, for example. Similarly, theproviding step (b) may comprise the step of obtaining the insert fromany manufacturer or vendor. By way of example, in one embodiment, theinsert may be permanently attached to the canister along its base 229.Preferably, the bond would be formed such that the groove 226 remains acommunication channel. Thus, the bonding should not substantially blockor plug the groove 226. In one embodiment, the insert is bonded orpermanently attached along its bottom face to an interior side of thecanister. A suitable solvent bond includes, for example, any plasticadhesive including without limitation ABS, acrylic, polystyrene, andpolycarbonate solvents such as cyclohexanone. With the insert andcanister forming one integral structure, fluid may be inserted into thereservoir 227 and the cap 223 can be placed over the rim of the canisterto seal the fluid within the irrigator device for transport or shipment.

FIG. 12a depicts an exploded view of another embodiment of a nasalirrigator. Similar to the above devices, the nasal irrigator comprises amain canister 240 with an air exit port 245 and a rim 243 surrounding areservoir 247 for holding fluid. The air exit port 245 extends beyondthe rim 243 of the irrigator and has at least one exit hole at the topsufficient to deliver an airstream that is able to atomize fluid anddeliver an aerosol. The main canister may also comprise the foot section246 for stability. In addition, if desired, the canister may compriseone or more horizontal marks or lines to indicate specific fluid levels.

FIG. 12b depicts an embodiment of the insert 241 with a base 248 thatfits within the main canister 240, wherein the insert has a bottom facewith at least one groove 244 to form a communication channel between thecanister 240 and the common bell housing 249. In one embodiment, asdepicted in FIG. 12 b, the groove at the bottom of the insert 241 mayextend from the outside edge of the bottom face to a peripheral groovesurrounding the opening of the common bell housing. The insert furthercomprises an extension 250. As depicted in FIGS. 12a and 13 a, in oneembodiment, the extension 250 protrudes outwardly from the mid-sectionof the insert 241 above the common bell housing 249. In otherembodiments, however, the extension may also extend from another pointalong the insert, from the common bell housing to any point closer tothe exit 253 of the fluid channel. The extension 250 forms a top, orlid, to the canister 240 that mates with the rim 243 of the canister. Inone embodiment, the extension comprises a downward concave shaperelative to a plane substantially perpendicular to the fluid channel;or, relative to the top surface of the lid. In one embodiment, theextension comprises a two-step diameter 257 to mate with the rim 243.The insert 241 further comprises one or more apertures 251 around thefluid channel, each of the apertures lining up with a vertical groove252 along the exterior of the fluid channel 262. The groove 252 runsvertically from a point below the exit hole of the fluid channel 253down to an aperture 251 in the extension 250. During use, the deflectedfluid will begin to flow back down the vertical groove 252. The aperture251 communicates with the inner chamber formed by the mating of the maincanister 240 and insert 241. As fluid exits the inner reservoir, avacuum is created that actually pulls the deflected fluid back into thereservoir 247 through the aperture 251, thereby ensuring maximum usageand minimized waste of the fluid.

The irrigator further comprises a cap 242 without holes that fits overand inserts into the fluid channel 253 and the air exit port 245 to sealthe reservoir from the air exit and fluid exit. The cap comprises anelongated portion 256 to ensure a good fit over the tube portion.Optionally, the cap may comprise a flattened edge 255 to help withalignment with the apertures 251 of the insert 242 and also help withthe grasping the cap 242. The bottom portion 258 of the cap mates with aportion of the top face of the extension. Thus, as best depicted in FIG.12 a, the bottom face of the cap 242 is relatively upwardly convex inone embodiment to mate with the downwardly concave extension 250. Thecap 242 further comprises one or more projections 254 on its bottomface, which mates with the apertures 251 of the extension. Inparticular, the projection 254 aligns with and seals the aperture 251when the cap 242 is placed over the insert 241, as best shown in FIG.14. Thus, the number of projections 254 on the bottom face of the cap242 should equal the number of apertures 251 in the insert 250. As bestdepicted in FIG. 13 b, the cap further comprises a sealing plug 259 thatprojects into and fits within the exit hole of the fluid channel 253 inthe insert 241 and the air exit port 245, thereby sealing the nasalirrigator.

Similar to the embodiments described above with regard to FIGS. 9-11, inorder to make a disposable device in accordance with one aspect of thepresent invention, the canister 240 and the insert 241 are affixedtogether such that the insert 241 and the canister 240 together form anintegral or single piece. In embodiments comprising an extension 250extending from the insert to the rim of the canister (as depicted inFIGS. 12-13), the extension may form a top that mates with the rim ofthe canister and the edges of the extension may be permanently affixedto the rim of the canister. Thus, in one embodiment, it is the extensionthat is permanently affixed to the rim of the canister by way ofbonding, for example. In another embodiment, the extension may form atop that mates together with a portion of the canister. A suitablesolvent bond includes, for example, any plastic adhesive includingwithout limitation ABS, acrylic, polyacetal, polyethylene, polyester,polypropylene, polystyrene, or polycarbonate solvent, UV-cured adhesive,heat or ultrasonic welding or over molding of materials. Bonding withsuch materials can be performed by any means known in the art. Havingthe insert and canister as a single integral piece, fluid may beinserted into the reservoir 247 and the cap 242 can be placed over theexit hole 253 and the aperture(s) 251 of the insert 241 to seal thefluid within the irrigator device for transport or shipment. The capsits over the tube portion of the fluid channel and the fluid within thereservoir remains sealed within the irrigator device until ready foruse. FIG. 14 depicts an assembled, sealed device 260 ready fortransport.

As with the above embodiments, the orifices of the fluid channels shouldbe positioned relative to the air exits so as to create a venturi effectwith the pressurized gas expelled from the gas tubes. Thus, the affixingstep should account for this positioning. Because the fluid channelexits in the insert are larger than the air exits, when air is forcedthrough the air exits at an appropriate volume and speed, fluid in thereservoir is drawn up into the space between the insert and air exitsports. When this fluid meets the subsequent airstream it is atomizedinto particles conducive to deposition in the upper airway.

FIG. 15 is an exploded view of an embodiment of a nasal irrigator devicecomprising a canister section 270, an insert 271, and a filter 272.Similar to the above devices, the canister section 270 comprises acanister 273 with reservoir 275 and an air exit port 276 having an exithole 277. The canister section 270 also comprises one or more feet 274beneath the canister 273; and the insert 271 comprises a base 278 thatfits within the reservoir of the canister and at least one fluid channel280 with an exit hole 281. As described above, the insert and canistersection once formed, shaped, molded or obtained, are affixed to oneanother.

In one embodiment, the nasal irrigator device further comprises a filtercomponent 272 that may be inserted over the insert 271. The filtercomponent 272 comprises a filter 284 comprised of a mesh structure withholes small enough to prevent any particulate matter or mucus that runsout of the nose from entering the reservoir 275, while allowing theirrigating or medicating fluid to run back into the reservoir 275 to bere-circulated or re-used. Suitable materials from which to create thefilter are plastic, metal, carbon fiber, or other fiber. In embodimentscomprising more than one fluid channel, the filter component alsocomprises a crossbar component 283. In one embodiment, the crossbar 283is an integral part of the filter component 272. However, it should beunderstood that the crossbar 283 could also form a separate component,which is detached from the filter, and remains optional.

FIG. 16 is a perspective view of an assembled irrigator having an inserthaving two fluid channels 280 and a filter 284 with the optionalcrossbar 283, wherein the insert is affixed to the canister to form onesingle integral structure. As described above, in one embodiment, theinsert is affixed to the canister by way of bonding. The bonding maycomprise the joining of the bottom face of the insert base to thecanister or the joining of the periphery of the base to the canister. Inone embodiment, the insert may be affixed to the canister by permanentlybonding the periphery 282 of the filter to the rim of the insert. Asbest depicted in FIG. 17, the filter 284 surrounds the tube portion 280of the insert and extends from the rim of the canister to the tubeportion 280, substantially covering the opening of the canister suchthat when in use, the filter prevents particulate matter from enteringthe reservoir.

With reference to FIGS. 12 and 13, where the nasal irrigator comprisesan extension, in one embodiment, a filter entirely covers or fits withinthe apertures 251 in the extension 250 to similarly keep particularmatter out of the reservoir and separate from the fluid forre-circulation. The filter may slide over the fluid channel of 241 ormay be bonded over or under the apertures 251 or even molded into theinsert 241.

FIGS. 19A and 19B show an exploded view of a portable nasal irrigator inaccordance with an embodiment of the present invention. The portableirrigator comprises four sections. The first major section is the maincanister 300, which comprises a reservoir 305 for receiving fluid. Themain canister 300 further comprises an air exit port 301. As depicted inthe figures, the air exit port 301 may extend above the top edge of themain canister 301. However, in alternate embodiments (not shown), theair exit port 301 may be even with or recessed within the edge orportions of the edge of the main canister 300. While the reservoir isdepicted as substantially circular, it should be appreciated that thereservoir may comprise any shape. In one embodiment, the reservoircomprises an oval shape. Preferably, the reservoir should be shaped toallow for the receipt of a maximum amount of fluid.

Returning to the embodiment depicted beginning at FIG. 19A, the maincanister further comprises a curved wall 302 surrounding the opening tothe reservoir 305. The curved wall 302 comprises a convex shape thatextends downwardly around the periphery of the opening into a bottomgenerally rectangular opening configured to mate with a pressurized airsupply, as further discussed below. When viewed from below, the maincanister 300 thus comprises a generally hollow portion surrounding thereservoir portion 305.

The second major section of the portable irrigator is the insert 307,which comprises a base 308 that fits within the reservoir section 305 ofthe canister. As depicted in FIGS. 19A and 19B, the base 308 iscircular. However, the base may comprise any number of shapes so long asit fits within the canister. The insert comprises a fluid channel 309with one end at the bottom of the reservoir 305 and one end that ispositioned in the airstream so that the airstream creates a negativepressure in each tube that draws fluid into the airstream where it isatomized. The end positioned in the airstream comprises an exit hole313. The fluid channel 309 is slightly larger in diameter than the airexit port 301 of the main canister 300, thereby providing a small space(preferably 0.0001″ to 0.010″ (0.00254-0.254 mm)) between the outersurface of the air exit ports and the inner surface of the fluidchannels. This space allows fluid from the reservoir 305 to proceedupward between the air exit port 301 and the fluid channel 301 untilbeing expelled by pressurized air. When the insert 307 is installed inthe main canister 300, the orifice 313 of the fluid channel 301 ispositioned relative to the air exit 301 so as to create a venturi effectwith the pressurized gas. Because the fluid exit in the insert 313 islarger than the air exits 301, when air is forced through the air exitsat an appropriate volume and speed, fluid in the reservoir 305 is drawnup into the space between the insert and air exit port. Thus, when thisfluid meets the subsequent airstream it is atomized into particlesconducive to deposition in the upper airway. The airstream is sufficientto penetrate the nasal cavity above the inferior turbinate so as todeposit the fluid and provide a washing, irrigation, or deposition tothe upper reaches the nasal cavity. The fluid channel size may beadjusted to change the particle size of the mist.

The insert 307 may be keyed in at least one location with the reservoir305 to ensure that the insert does not rotate in relation to the exitport 301 of the main canister 300 and to aid in centering of the insert307 and its fluid channel 309 on the air exit port 301. In oneembodiment, the insert may also include a feature to ensure that it isinserted into the main canister in only one orientation.

At least one channel is located in the bottom of the insert 307 to actas a conduit for fluid from the reservoir 305 to enter the base 308 ofthe insert. As best depicted above in FIGS. 9b and 12 b, the bottom faceof the base 308 of the insert 307 comprises at least one channel orgroove that forms a communication channel between the canister and theinsert. The groove extends from the outside of the base to the inside ofthe insert. The base should comprise at least one groove but may alsocomprise more than one, as depicted in FIG. 9 b. The number of groovesas well as the width and depth of the groove will help regulate the flowof fluid up to the point that the airflow takes over the upper limit offlow. In one embodiment, the grooves may range in width from about0.005″ to about 0.150″ (0.127 mm to about 3.81 mm). In one embodiment,the grooves may range in depth from about 0.001″ to about 0.050″ (0.0254to about 1.27 mm).

The canister 300 and the insert 307 may or may not be affixed togetherto form one integral piece. The bond may be formed by any means known inthe art including without limitation use of a solvent bond, glueUV-cured adhesives, mechanical attachment, heat forming, orradiofrequency or ultrasonic welding. Alternatively, the canister andinsert may be affixed together via a mechanical interlocking elementsuch as a friction fit or a snap fit to form a temporary connection.

The insert further comprises an extension 311. As depicted in FIGS. 19Aand 19B, the extension 311 protrudes outwardly from the insert 307. Theextension 311 may extend from any point along the insert to form a top,or lid, to the canister 300. In one embodiment, the extensionsubstantially covers the opening of the reservoir 305. In anotherembodiment, the extension entirely covers the opening of the reservoir305. In one embodiment, the extension comprises a downward concave shaperelative to a plane substantially perpendicular to the fluid channel;or, relative to the top surface of the lid. In one embodiment, theextension comprises a two-step diameter (not shown) to mate with a rimof the opening. The insert 307 further comprises one or more apertures314 around the fluid channel, each of the apertures lining up with avertical groove 310 along the exterior of the fluid channel 309. Thegroove 310 runs vertically from a point below the exit hole of the fluidchannel 309 down to an aperture 314 in the extension 311. During use,the deflected fluid will begin to flow back down the vertical groove310. The aperture 314 communicates with the inner chamber formed betweenthe main canister 300 and insert 307. As fluid exits the innerreservoir, a vacuum is created that actually pulls the deflected fluidback into the reservoir 305 through the aperture 314, thereby ensuringmaximum usage and minimized waste of the fluid.

Another section of the portable nasal irrigator is a removable cap 315of the nasal irrigator. The cap 315 comprises no holes and fits over andsubstantially covers the fluid channel 309. Optionally, the cap maycomprise a flattened edge (as shown above in FIG. 12A) to help withalignment with the apertures 314 of the insert 307 and also help withthe grasping the cap 315. The bottom portion of the cap should mate witha portion of the top face of the extension. The cap 315 furthercomprises one or more projections 312 on its bottom face, which mateswith the apertures 314 of the extension. The number of projections 312on the bottom face of the cap 315 should equal the number of apertures314 in the insert 307. As best depicted in FIG. 22, the cap comprises aprojection or sealing plug 323 that projects into and fits within theexit hole 313 of the fluid channel and extending into the air exit port301 of the canister to seal the reservoir from the air exit port andfluid channel exit when the cap is placed over the insert.

A fourth section of the portable nasal irrigator is a handheldpressurized air supply source 317 onto which the main canister 300 fits.Preferably, the pressurized air supply source is a handheld aircompressor. As shown in FIG. 19B, the air supply source comprises an airoutlet 319, which connects with the air inlet 303 of the main canister.In one embodiment, the canister snap fits onto the pressurized airsupply source 317 to form an airtight seal between the air inlet 303 andthe air outlet 319. In one embodiment, the airtight seal may comprise anO-ring or soft plastic portion between the air inlet 303 and the airoutlet 319 (not shown). An air input 320 supplies air to the pressurizedair supply source 317 and may comprise a filter to keep out foreignmaterials. In order to accommodate for the air input 320, the maincanister 300 comprises an air vent 306, which allows air into the airinput 320 without interrupting the airtight seal between the canister300 and air supply source 317. The bottom rim 304 surrounding thegenerally rectangular bottom of the main canister 300 is fashioned tofit onto the pressured air supply source 317 such that no wiring orconnecting tubing is required. Thus, unlike previous embodiments, a footsection at the bottom of the main canister is not necessary in order tostabilize the canister on a substantially flat surface. Instead, thepressurized air supply connects directly and immediately with the maincanister.

While the pressurized air supply source 317 is depicted as having agenerally rectangular shape, the source 317 may comprise any shape solong as it remains portable and capable of directly attaching to themain canister without the use of tubing. In one embodiment, thepressurized air supply source 317 is substantially rectangular.Preferably, the pressurized air supply source comprises an ergonomicshape to increase user comfort. For example, the air supply source 317may comprise a grasping or gripping portion having a shape thatcorresponds to a palm of a hand of the user. The gripping portion may beon one side of the air supply source, with a second opposing sidesubstantially flat; or it may comprise curves substantially around theentire periphery of the air supply source such that user may hold theportable device lengthwise with his or her hand around substantially theentire pressurized air supply source 317. In one embodiment, the airsupply source 317 comprises an ergonomic grasping portion. In anotherembodiment, the pressurized air supply source 317 is substantiallyrectangular with curves and features that make it easy to hold in thehand. In order to allow for portability of the irrigator device, thepressurized air supply should generally be small enough to easily carryor transport. In one embodiment, the pressurized air supply sourcecomprises a ratio of width: length:depth of about 2.5:3:1. In anotherembodiment, the pressurized air supply source comprises a ratio ofwidth: length: depth of about 9:15:5. In one embodiment, the pressurizedair supply source comprises a ratio of width: length: depth of betweenabout 2.5:3:1 to about 9:15:5. By way of example, in one embodiment, thelength may be about 15.5 cm, the width may be about 9.2 cm, and thedepth may be about 5.7 cm. It should be recognized that any number ofsizes and dimensions is possible while maintaining portability.

The pressurized air supply source 317 may employ an AC/DC power supply.The source 317 is DC-operated and may include a rechargeable internalbattery or an external, detachable battery for easy exchange of depletedbatteries. The source 317 may further be operated using a power switch321 capable of turning on the air supply. The switch 321 may be anintermittent switch conveniently located on the air supply source 317such that a user may conveniently reach it with one of his or herfingers. In one embodiment, the air supply source 317 may also comprisean indicator for the level of charge on the battery (not depicted) or atimer that beeps at timed intervals to deliver medication evenly betweennostrils (not depicted). As described above, the pressurized air has apressure of 0.069-1.035 bar and an airflow rate of 1-12 liters perminute, producing a fluid delivery rate of 1-20 ml per minute.

FIG. 20 shows a front perspective view of an assembled portableirrigator as shown in FIGS. 19A and 19B, with the removable cappositioned over the device. Thus, when fully assembled with the cap inplace, the portable irrigator device is completely self-contained,prohibiting any leakage of fluids. As depicted in FIGS. 19A and 19B, inone embodiment, the pressurized air supply source 317 comprises aninternal battery, which may or may not be rechargeable. FIG. 21A shows aperspective view of an assembled portable irrigator in anotherembodiment, with a detachable battery compartment 322 for one or morebatteries which may or may not be rechargeable. In this embodiment, thebattery compartment may detach from a portion of the pressurized airdevice by way of a switch element. FIG. 21B shows a perspective view ofa portable irrigator as depicted in FIG. 21A, with the batterycompartment 322 detached from the air supply source 317.

FIG. 22 shows a cross sectional detailed view of the main canister 300,insert 307 and cap 315 portions in an assembled portable irrigatoraccording to one embodiment of the present invention. As best depictedhere, the air exit port 301 and fluid channel 309 form two overlapping,concentric, tapered tubed having the requisite gap or space, asdescribed above, between them in order to allow for the venturi effect.When connected to the pressurized air supply source 317, the air inletof the main canister plugs directly the supply source or air compressorby way of its air outlet. An alternate embodiment depicted in FIG. 23shows that the air exit port 301 and the fluid channel 309 may alsoinclude a common bell housing as with previous embodiments.

FIGS. 24-32 depict another embodiment of a portable irrigator 330. Theportable nasal irrigator 330 comprises: a pressurized air supply source380 comprising a rim 331 surrounding an opening 332 on one end with anair outlet 333 therein; a canister 370 with a reservoir 373 for holdingfluid recessed within the opening 332, the reservoir 373 surrounding atube 374 tapering to an air exit port 376; and an insert 360 comprisinga base 391 that fits within the reservoir, an extension 367 above thebase 391 protruding outwardly to the canister 370, and a fluid channel394 (shown best in FIG. 25B and 28) that fits over the elongated tube374, said fluid channel 394 having a discharge port 364 concentricallyaligned with the air exit port 376, said discharge port 364 located atan uppermost end of the irrigator 330 above the extension 367, therebyproviding a small space between the outer surface of the air exit portand the inner surface of the insert, creating a fluid conduit thatallows fluid from said reservoir to be drawn upward between the air exitport and the fluid channel and expelled as a mist in an aerosol plumethrough exit holes in the fluid channel due to a venturi effect createdby pressurized air from the air exit port. The fluid is thus expelledfrom the reservoir 373 as a mist through the discharge port 364. Thecanister 370 comprises: a lip 372 extending above and resting on the rim331 of the pressurized air supply source 380; and an air inlet 334 belowthe reservoir 373, the air inlet 334 connected to the air outlet 333;and wherein the pressurized air supply source 380 houses an airflowregulating system. The canister 370 is retained to and sealed togetherwith the pressurized air supply source 380 by the connection of a matingportion 383 and a tab 378, as further described below. A seal betweenthe air outlet 333 and the tube 374 of the main canister 370 also helpsmaintain the connection between the canister 370 and the pressurized airsupply source 380, as shown in FIGS. 26B and 30.

Similar to the above embodiments, the portable irrigator 330 comprises acap 350, insert 360, and a cup or canister 370. FIG. 24 shows anexpanded view of each of these components and their general placementover one another and the pressurized air supply source 380. FIG. 25shows the canister 370 connected to the pressurized air supply source380, while FIG. 27 shows an assembled irrigator 330 with placement ofthe insert 360 over the canister 370 while connected to the pressurizedair supply source 380 for usage by a consumer, and FIG. 29 showsplacement of the cap 350 over the insert for storage or transport by aconsumer.

As depicted in FIGS. 24 and 25B, the pressurized air supply source 380is a generally elongated structure comprising a concave opening 332 withan airflow regulating system therein, which will be further describedbelow. In one embodiment, the pressurized air supply source 380comprises a first larger bottom depth and a second smaller top depth,with an angled surface there between. The shape of the pressurized airsupply source thus provides for a grip zone along the length of thepressurized air supply source for consumer handling. The size may be anysize that allows for handheld usage. The narrow neck top accommodatessingle-handed use, while the wider bottom section accommodates atwo-handed grip, if desired.

A single membrane 390 along one external side of the pressurized airsupply source 380 incorporates a single ribbon connector (not shown) andcomprises an indicator light 393, and a raised dome switch 392integrated therein, to turn the irrigator on or off. In one embodiment,the switch 392 is an intermittent operating switch. In anotherembodiment, the switch is a latching switch. In one embodiment (notshown) the switch is discrete from the other components.

In the embodiment depicted in FIG. 24, the indicator light 393 comprisesa light pipe, which may house one or more light therein. However, inother embodiments, the indicator light may comprise any number of shapesor symbols including, for example, any number of icons or shapes todepict battery power. By way of example, the indicator light 393 maycomprise a light pipe, a battery icon, or gas gauge, which may comprisea number of rectangles in a line on the switch. An indicator light mayindicate when the irrigation device is charging in one embodiment; or,when the irrigator requires charging in another embodiment; or when thedevice is operating, in another embodiment. The indicator light mayilluminate for a sufficient amount of time for a user to recognize aneed for charging after use. For example, the indicator light mayilluminate for 5-30 seconds after an operation to indicate when chargingis required. In one embodiment, the indicator light may illuminate toindicate when charging is needed while there is still sufficient powerto run the device for a full expected dose; ensuring the user is awareof the need to charge and avoid a missed dose. In one embodiment, theindicator light is an LED light source. The LED light source may be asingle color LED, multi-color LED or multiple LEDs of a single color orof different colors. In one embodiment, the indicator light uses a lightpipe 393 to transmit light to the outside of the device.

In one embodiment, the single membrane 390 contains all electricalcomponents externalized to the user except a power jack, which may beoptionally used, for example, to power the irrigator or charge arechargeable battery within the pressurized air supply source or tooperate the device when the battery is discharged such that the devicecannot be operated with the battery alone. In one embodiment, theirrigator comprises a tethered cover for the power jack designed toreduce fluid and dust ingress to the device when the power supply is notplugged into the device. Optionally, in one embodiment, an audibleindicator is incorporated into the pressurized air supply source of theirrigator to indicate a set time of operation, a need for charging, orthe initiation of a charge. On an external side, opposite to themembrane 390, the pressurized air supply source 380 comprises the angledsurface having a cover or cap 450 for a filter for incoming air, furtherdescribed below.

With reference to FIG. 25A, the canister 370 is recessed within thepressurized air supply source 380, which has a concave opening. Morespecifically, a bottom portion of the canister rests within thepressurized air supply source once the canister 370 is attached to thepressurized air supply source 380. A lip 372 extends above thepressurized air supply source 380 and rests on the rim 331 of thepressurized air supply source. In one embodiment, the lip is of anelliptical shape. The lip 372 surrounds the entirety of the topperimeter edge of the canister 370 and prevents spills from the innervolume or reservoir 373. In one embodiment, the periphery 371 iselliptically shaped to match an elliptical opening of the pressurizedair supply source 380. A flat portion 377 assists with proper placementand alignment of the canister 370 in one embodiment. Thus, thepressurized air supply source 380 and the canister 370 may employ visualor tactile alignments marks to ensure the user is able to easily jointhe two components. As with the above-discussed irrigator embodiments,within the reservoir 373 is a tube portion 374 that tapers into an airexit port 376, which is above a rim of the irrigator. In one embodiment,the air exit port 376 comprises a size of between 0.020″ and 0.060″(0.508 mm-1.524 mm) in diameter and a web-thickness or hole length ofbetween 0.030″ and 0.200″ (0.762 mm-5.08 mm). In one embodiment, thecanister 370 is reusable. In one embodiment, the canister 370 isdisposable.

In one embodiment, as best shown in FIGS. 24 and 26A-B, the canister 370is positively held to the pressurized air supply source 380 by a lockingmechanism, which is comprised of at least one tab 378 on the canister370 that interfaces with a mating portion 383 that captures the tab 378.The mating portion 383 protrudes from and is located within the concaveopening 332 of the pressurized air supply source 380 and may compriseany shape capable of locking with a corresponding tab 378 of the maincanister 370. In one embodiment, the mating portion 383 comprises one ormore rounded or curved protruded edges with a thicker end piece at oneend under which one or more tabs 378 may lock. One or more tabs 378 onthe base of the canister 370, below the reservoir 373, then securelyfits within the upper end of the pressurized air supply source 380 byway of the locking mechanism. The tab 378 or bottom of the main canister370 fits within an opening 332 of the pressurized air supply source 380,and the canister 370 is then turned in the direction of arrow A. The tab378 then slides under the mating portion 383 until the canister 370locks into place. The locking mechanism in effect presses the canister370 into a seal that seals the air channel between the canister 370 andthe pressurized air supply source 380. In one embodiment, the tab 378has a protrusion, bump or other feature that mates with a similarfeature on the mating portion 383 to securely lock the two piecestogether during operation and provide a tactile and auditory indicationthat the mating process is secure and the canister 370 and thepressurized air supply source 380 are properly connected.

Similar to the portable irrigator described above in FIGS. 19-23, thecanister 370 comprises an air inlet 334 at its bottom end below thereservoir 373, which connects to an air outlet 333 of the pressurizedair supply source 380. In one embodiment, the air inlet 334 comprises anextended bottom portion to aid in sealing with the pressurized airsupply source 380. In one embodiment, air outlet 333 of the pressurizedair supply source 380 comprises an air outlet elbow 382 connected to theair inlet 334 of the main canister 370. An outlet tubing 385 on anopposing end of the elbow 382 connects to a pump 386 as furtherdescribed below in one embodiment. More specifically, the outlet tubing385 connects the air outlet 333 to a pump outlet 389, as shown in FIG.31. In one embodiment, the air outlet elbow comprises an angle ofbetween about 30 degrees to about 90 degrees in between itssubstantially vertical portion extending down from the air inlet 334 andits somewhat horizontal portion connected to the tubing 385, sufficientto circumvent a motor 384 within the pressurized air supply source 380,as best shown in FIG. 31. In one embodiment, an o-ring 381 helps form aseal between the canister 370 and the air outlet elbow 382 of the airoutlet 333.

Referring now to FIGS. 27-28, when assembled, the irrigator comprises aninsert 360 placed over the canister 370. As shown in FIG. 27, only theperiphery 371 with the rim 372 of the canister 370 is visible when theinsert is present for usage of the irrigator. Generally, the insert 360,also shown in FIGS. 28 and 30, is substantially similar to the insertsdescribed in above embodiments and can thus comprise one or more of thelimitations described above. The insert 360 comprises a base 391 thatfits within the reservoir 373, an extension 367 above the base 391protruding outwardly to the lip 372 of the canister 370, and a fluidchannel 394 that fits over the tube 374, the elongated fluid channel 394having a somewhat larger bottom diameter converging up to a smallerdiameter at its top end 362. The discharge port 364 is concentricallyaligned with the air exit port 376. In one embodiment, the base 391 ofthe insert 360 comprises a curved surface flush with an inner bottomsurface of the reservoir 373. The fluid channel 394 tapers from onediameter around its bottom opening to a smaller diameter at its top end362 with the discharge port 364. The fluid channel 394 is slightlylarger in diameter than the tube 374 along the entire length of both thefluid channel 394 and the tube 374, with the tube 374 comprising asimilar conical shape having the smaller diameter on its top end. Thedistance between the outer surface of the tube 374 and the inner surfaceof the fluid channel 394 should be sufficient to create a venturieffect. When used, the discharge port 364 is the uppermost part of theirrigator 330, with no additional barrier or structure breaking up thesize or flow of the fluid drawn up from the canister 370. In oneembodiment, the distance between the outer surface of the tube 374 andthe inner surface of the fluid channel 394 is about 0.0001 to about0.010 inches (about 0.00254-0.254 mm)). One or more bumps 369 may beused, by way of example, to secure a tight fit and/or proper alignmentbetween the insert 360 and the main canister 370.

An indicator 368 (best depicted in FIG. 27) may be used on one side ofthe extension 367 to assist with alignment of the flat portion 377 onthe main canister 370. The extension 367 comprises a rim 361 positionedon top of the main canister 370 and below the discharge port 364,through which mist will pass for irrigation of a nasal passage. In oneembodiment, the rim 361 engages the lip 372 of the canister 370. In oneembodiment, the extension 367 is slightly concave.

Similar to the inserts described above with extensions, the extension367 comprises at least one groove 365 extending vertically along anexterior of the fluid channel 394 to an aperture 366 at the bottom ofthe fluid channel 394 or within the extension 367 adjacent to the fluidchannel. The groove 365 runs vertically from a point below the dischargeport 364 of the fluid channel 362 down to the aperture 366. During use,deflected fluid will begin to flow back down the vertical groove 365.The aperture 366 forms a channel of communication back into thereservoir 373, which is an inner chamber formed by the mating of thecanister 370 and the extension 367 of the insert 360. As fluid exits theinner chamber, a vacuum is created which is relieved by the inflow ofair and the deflected fluid into the reservoir 373 through the aperture366, thereby ensuring maximum usage and minimized waste of the fluid. Inone embodiment, the aperture 366 in the extension 367 is located at abottommost level of concavity of the extension 367.

Similar to the embodiment above related to FIG. 12 b, the insert 360 hasa bottom face with at least one groove (as depicted as FIG. 25B) forminga communication channel between the canister 370 and the insert 360. Inone embodiment, as depicted in FIG. 12 b, the bottom face of the insert360 may also comprise a peripheral groove surrounding the bottom openingof the fluid channel to which the groove may extend from the outsideedge of the bottom face. In one embodiment, the groove extends from theoutside of the base to the inside of the insert. The base shouldcomprise at least one groove but may also comprise more than one. Thenumber of grooves as well as the width and depth of the groove will helpregulate the flow of fluid up to the point that the airflow takes overthe upper limit of flow. In one embodiment, the grooves may range inwidth from about 0.005″ to about 0.150″ (0.127 mm to about 3.81 mm). Inone embodiment, the grooves may range in depth from about 0.001″ toabout 0.050″ (0.0254 to about 1.27 mm). In one embodiment, the base 391of the insert comprises a curved surface flush with an inner bottomsurface of the reservoir of the main canister 370.

A cap 350 is optional but must be removed during use. When present, asshown in the assembled perspective view of FIG. 27, the cap helps sealfluid within the irrigator to provide for storage or travel with theirrigator. The cap comprises no holes and covers the entire fluidchannel 394 of the insert 360, comprising a sealing plug (best shown inFIG. 30) for the discharge port 364. As with above embodiments, the cap350 fits over the fluid channel 394 and comprises a sealing plug, in oneembodiment, which projects into and fits within both the discharge port364 and the air exit port 376 of the canister 370 to seal the reservoir373 from the air exit port 376 and fluid channel discharge port 364 whenthe cap 350 is placed over the insert, as shown in the assembled view ofFIG. 27. Similar to above embodiments, the sealing plug of the cap mayalso seal or fit within only the discharge port 364 in otherembodiments. The cap 350 may comprise an elongated conical shape in oneembodiment to ensure a good fit over the insert and its apertures.Optionally, the cap 350 may comprise a flattened edge to help withalignment over the insert 360. The bottom portion 351 of the cap mateswith a portion of the top face of the extension 367 and thus its shapewill depend on the curvature of the top face of the insert's extension.The cap 350 may optionally comprise one or more vertically extendingindentations 352 or curved ends 353, as best shown in FIG. 29, to matewith the grooves 365 and/or apertures 366, respectively, of the insert.

Beginning with FIG. 30, one embodiment of an airflow regulating systemwithin the contiguously attached pressurized air supply source 380 isdepicted. Preferably, the internal components of the pressurized airsupply source 380 are placed to enhance stability and feel of theirrigation device with a low center of gravity and torque generated bythe motor being in the vertical axis. Such an arrangement helps engagethe large muscles of the forearm for improved stability.

In one embodiment, the airflow regulating system comprises: a pump 386in communication with a motor 384 and the air inlet 334 (shown in FIG.26B); and a filter 451 (shown in FIG. 33B) for filtering incoming air,the filter 451 comprising an inlet air manifold 401 connected to thepump 386 and sealing against a pump air inlet post 395 of the pump 386,as further described below. The pressurized air supply source 380further comprises a circuit board 388. In one embodiment, the circuitboard uses a pulse-width modulation to ensure consistent motor speed. Inone embodiment, the circuit board uses a programmable digital control toensure consistent motor speed. In one embodiment, the circuit board alsocharges the battery from an external AC/DC converter and ensures thatthe motor behaves consistently whether powered by an AC/DC converter orby the battery. In one embodiment, the circuit board communicates thestatus of the battery to the user via an LED on the outside of the unit.In one embodiment, the motor 384 is a brushed motor. In one embodiment,the motor 384 employs caged brushes. In another embodiment, the motor384 is a brushless motor. The outlet tubing 385, described above,circumvents the motor 384 in one embodiment, to connect the canister 370to a pump outlet 389 of the pump 386. A battery 387 within thepressurized air supply source drives the motor 384 in one embodiment. Inone embodiment, the battery 387 is a rechargeable lithium ion battery.In some embodiments, the battery 387 may be accessible or removable by auser. In one embodiment, the battery is not accessible to a user. Inanother embodiment, the motor 384 is driven by an external power supply.In one embodiment, a motor controller board utilizes pulse widthmodulation to control the motor speed so as to maintain a very narrowband of motor speed to regulate the airflow generated by the pump. Morespecifically, the motor will operate within a wide range of +/−15% andwithin an operating range of +/−4% of its set point. In one embodimentmotor wires 396 are twisted to mitigate electrical noise to meetIEC-60601-1 third edition requirements for electrical emissions. In oneembodiment, the motor wires 396 may also include an electronic filterthat may incorporate ferrites to suppress noise. In yet anotherembodiment, motor wires 396 are comprised of a coaxial cable to mitigateelectrical noise to suppress noise. In one embodiment, the motor 384 andthe pump 386 contact the pressurized air supply source 380 throughvibration dampers.

FIGS. 33A and 33B depict partial views of opposing sides of thepressurized air supply source 380, with either half of the pressurizedair supply source removed to better reflect some of its adjacentinterior components; in particular to depict the air inlet manifold or401 and filter 451 under the filter cover 450, which resides within theopening 400 of the pressurized air supply source 380. The air inletmanifold 401 is a small box that forms a small fitting that seals aroundthe air inlet of the pump, eliminating the need for a tube-likecommunication from the outlet to the pump 386. An opening 400 is locatedalong the angled surface of the pressurized air supply source 380 in oneembodiment. When assembled, the filter cover 450 is visible on anexternal side of the pressurized air supply source, within the opening400. In one embodiment, the filter cover 450 may be removable for accessto the filter 451.

In one embodiment, the filter cover 450 is shaped to exactly match theopening 400 in the pressurized air supply source 380. As best shown inFIG. 34A, air inlet manifold 401 comprises a cutout 405, which alsomatches the opening 400, wherein the filter 451 is placed. The angledsurface 404 of the air inlet manifold 401 matches and seals against theinside of the pressurized air supply source 380. A cutout 402 forms anair channel within the air inlet manifold 401 to the air inlet of thepump. The cutout 402, perhaps best shown in FIG. 34B is at the bottom ofthe air inlet manifold 401 aligning with a centerline of the pump 386.Thus, the air pathway is centered within the air inlet manifold 401. Aflat bottom 403 of the air inlet manifold 401 rests on the pump 386. Theair inlet manifold 401 thus connects and seals against a pump air inletpost 395 of the pump 386 in one embodiment. In one embodiment, the airinlet manifold 401 comprises an anti-rotation tab 407 along its bottomside to prevent movement. In one embodiment, the air inlet manifold 401may comprise more than one anti-rotation tab 407 adjacent to the cutout402.

The filter cap or cover 450 is shown in more detail in FIG. 35. Thefilter 451 within the air inlet manifold 401 may be composed of 80 ppireticulated polyurethane foam in one embodiment. In one embodiment, thefilter 451 is pressed and shaped within the filter cover 450. In oneembodiment, the filter 451 is accessible to a user for replacement orcleaning. Access to remove or replace the filter 451 may be accomplishedby any means known in the art. A centerpiece 454 may comprise a raised,arch ridge, in one embodiment, for removal of the filter cover 450 fromthe manifold 401. Face 452 is flush with the pressurized air supplysource 380. Vent 453 opens to filter 451 to allow air to pass andcenterpiece 454 secures the filter inside the filter cover 450 andprovides for a place for a user's fingers to insert the filter cover 450into the manifold 401.

As described for previous embodiments, the portable nasal irrigator 330creates a variable particle size up to 100 microns under a pressure of1-15 psi (0.069-1.0345 bar), creating a pressurized airflow that enablesthe resultant air-mist stream to stent-open the soft tissues of theupper airway and reach the whole nasal cavity independent of thepatient's breathing. A vast majority of the particles are sized at about20 microns. In one embodiment, the mist expelled through the exit holecomprises air and fluid particles or droplets, 100% of particles ordroplets being greater than 5 microns in diameter and 99.8% of theparticles or droplets are greater than 10 microns in diameter. In oneembodiment, the particle or droplet diameter distribution has a modecentered around 23 microns, the mist is expelled under a pressure of1-15 psi with a fluid delivery rate of 1-20 ml per minute, and airflowof 3-8 liters per minute, creating an air column that drives theresultant mist past the nasal valve and antrum of the nose to coat theturbinates, middle meatus to reach the posterior and superior regions ofthe nasal cavity and the paranasal sinus cavities without introducingthe aerosol into the lungs. In one embodiment, the air pressure rangesfrom about 3-12 psi (0.207-0.823 bar), with about 1-12 lpm of airflow,and a fluid delivery rate of about 1-20 ml per minute. In oneembodiment, the air pressure ranges from about 4-8 psi (0.276-0.552bar), with about 3.5-8 lpm airflow, and about 15 ml per minute fluiddelivery. The resultant aerosol mist reaches the area of the nasalcavity above the inferior and posterior to the nasal turbinate orchonchae to ensure that the mist reaches the areas of the sinus ostia toclear this area of the nasal cavity and enable the natural mucociliaryflow to clear the sinuses.

By way of example, a portable nasal irrigator device as described hereinmay be comprised of ABS, Polycarbonate, glass, stainless steel,styrolene, styrene-butadiene copolymer, co-polyester BPA-free plasticsor any other plastics appropriate for medical device use, and anycombination thereof. The device may further be comprised of anantimicrobial compound in some embodiments. In one embodiment, thecanister and insert are constructed of a BPA-free material. In oneembodiment, the canister is USP class VI compliant for the storage anddelivery of drugs. In another embodiment, no latex is used in theconstruction of the device.

In one embodiment, the portable nasal irrigator is “smart” which canalso be achieved through the use of an analog-digital hybridprogrammable controller/circuit board, allowing for programmableoperation of the device to fit the needs of the patient depending on thetherapy being delivered. Examples of this programmability includeabsolute run time for a single actuation, charge status of the batterywhen employed, absolute number of runs within a given period of time,and various overrides for these programmable features. For instance, toreduce abuse and diversion of controlled and addictive substances, thedevice could be programmed to allow no more than 5 actuations in a 5minute period, with a time limit of 3 minutes total for all actuations,and then no actuations until the next appropriate dosing period. Oneskilled in the art, armed with this disclosure, can envision any numberof permutations to this pattern. For instance, a pattern of use thatmight enhance absorption of a drug could include 5-subdoses over anhour, wherein the external indicators for the device help the user keeptrack of the timing of doses and even limit the window of dosesappropriate to the drug. This programmability may be performed at thefactory or by a technician or the caregiver. There is also a need forthe device to include memory to store patterns-of-use information, andthere is a need for this information to be communicated to a computer,smart phone or other device via a USB port, blue tooth connection, WIFI,cellular or other methods. There is also a need for the device toinclude a unique identifier, such as the global unique deviceidentification number associated with the US FDA global unique deviceidentification database. This identifier could be stored in the devicememory or on an embedded RFID chip or other such chip.

FIG. 36 depicts a block diagram of one embodiment of the programmablecircuit board. The programmable circuit board is a component of theairflow regulating system of a portable nasal irrigator device. Asmentioned with previous embodiments, the programmable circuit boardprecisely controls the motor speed to ensure the proper airflow, ensuresthe battery voltage is maintained for operation, and drives statusindicators to inform the user when the battery requires charging and isbeing charged. In FIG. 36, the circuit board may comprise a chargingcircuit connected to a either a power supply or a battery and a batteryvoltage monitor. The circuit board may also have any number ofanalog-to-digital converters and digital-to-analog converters forcontrolling either the power supply or the motor of the portable nasalirrigator. The circuit board may use a pulse-width modulation module ora programmable digital control to ensure consistent motor speed, and maybe programmed to control the motor speed regardless of battery power,such that the motor operation is discontinued when the battery voltageis no longer capable of maintaining the motor speed, without sputteringor altering the speed as the battery voltage drops. The circuit boardmay be connected to the status indicators to indicate whether thebattery needs charging or is charging, switches, and may include astatus indicator, either programmed as an alert to an external device oras a status indicator light, to notify the user that the batteryrequires charging such that there is at least one actuation of theportable nasal irrigator to deliver a full dose of the irrigator fluid.The circuit board may also be connected to various input/outputconnectors for connecting to other components of the portable nasalirrigator or to external data collection devices. The circuit board mayalso comprise a processor and memory devices (or any other tangiblenon-transitory computer useable medium) for automating the airflowregulating system.

The circuit board may be connected to a computer, smartphone, tablet, orany other computing device. By connecting the circuit board to acomputing device, the portable nasal irrigator may be programmed toperform certain tasks, like those further disclosed below. A computingdevice may be any electrical device capable of accepting stored programinstructions from a computer readable medium and processing thoseprogram instructions to perform a defined task. Such devices include,but are not limited to, a mainframe, workstation, desktop, laptop,notebook, or tablet computer, a database server, web server, or thelike. One of ordinary skill in the art will appreciate that theconstruction, choice of programming language, programming, operation,and functionality of such computer processing devices is well known,rendering further description of such devices unnecessary in thisregard.

The portable nasal irrigator may be extemporaneously programmed in anad-hoc fashion based on information provided with each prescriptioninformation provided with a drug and/or medical fluid. The prescriptioninformation may be contained in a smart chip, dot matrix, bar code orother encoded information that may be read from the drug and/or fluidpackage, and the portable nasal irrigator may have a smart chip reader,bar code reader, or other computing device capable of detecting andprocessing the encoded information. The encoded information processed bythe reader may then be used by the portable nasal irrigator to performin different ways.

A series of pre-determined scenarios may also be programmed into theportable nasal irrigator and accessed via a lookup table that includesall the run time, lockout periods, and other parameters. The scenariosmay be associated with the national drug code, a bar code, or any othersuch instruction that may be included with the drug to select ordetermine the appropriate pre-programmed scenario. The portable nasalirrigator, in this embodiment, may incorporate a reader to read theencoded prescription information. An example of the lookup table of thisexemplary embodiment is provided below:

Max run time Max run time Max runs Dispensing Max Scenario peractivation per interval per interval Period intervals Lockout 1  3minutes null null null null null 2 20 seconds 3 minutes 10 30 minutesnull null 3 20 seconds 3 minutes 10 30 minutes null 360 minutes 4  3minutes 3 minutes 10 30 minutes null null 5  3 minutes 3 minutes 10 30minutes null 360 minutes 6  3 minutes 3 minutes 10 30 minutes 2 360minutes

To further secure the usage of the portable nasal irrigator, theportable irrigator may incorporate technology to identify authorizedusers via a personal ID, e.g., fingerprint, eye scan, mobileapplication, ID card embedded with an RFID, or other identificationtechnology. For example, a mobile application may require a user toverify his or her identity before unlocking the portable nasal irrigatorfor use. An administrator (physician or healthcare personnel) may usethe mobile application to temporarily alter the information from thepre-determined scenario lookup table for the special needs of the userof the portable nasal irrigator. User identification may becross-checked against the drug prescription to ensure the portable nasalirrigator is used by the proper person, increasing safety for patients,in particular where multiple patients may use the same base unit withtheir own cup and insert.

In one embodiment, the airflow regulating system controls theperformance of the portable nasal irrigator by automating the motor andregulating the power supply. The airflow regulating system automates themotor to perform at certain motor speeds and at certain time intervals.The airflow regulating system may use lockout periods to prevent abuseand diversion of controlled substances, such as Ketamine, its analogsand metabolites that may be particularly subject to abuse. A lockoutperiod is a time period that the portable nasal irrigator will notactuate even though a user or an administrator may request actuation.When the airflow regulating system determines that a certain number ofactuations have been performed in a predetermined dispensing period, theairflow regulating system will lock and prevent any more actuations ofthe system until the lockout period is passed. An administrator of theportable nasal irrigator may program or set up the airflow regulatingsystem for a certain number of actuations of the system in a certaindispensing period before a programmed lockout period by directlyconnecting to the airflow regulating system or by other input/outputconnections, such as Wi-Fi, Bluetooth, Ethernet, etc.

In another embodiment, the airflow regulating system may control themaximum run time of the portable nasal irrigator by use of a timer. Themaximum run time prevents the portable nasal irrigator from being lefton or left running inadvertently. A timer on the programmable circuitboard may alert and trigger other components on the programmable circuitboard. The timer may be programmed or set up in any way a person ofordinary skill in the art would program or set up a timer. The airflowregulating system with the timer monitors the time the portable nasalirrigator delivers irrigation fluid, and calculates this monitored timetoward the maximum run time. This limitation of run time of the portablenasal irrigator may be used in conjunction with a lockout period. A useror an administrator may set up the portable nasal irrigator to lock andprevent delivering any more of the irrigation fluid once the airflowregulating system determines that the maximum run time has been reached,and will only allow the delivery of more irrigation fluid once a lockoutperiod has passed. Alternatively, the user or administrator may set upthe portable nasal irrigator to deliver fractions of a dosage ofirrigation fluid over a longer period of time than a full dosagerequires, and the airflow regulating system may compensate for this setup.

Run time, as used herein, may differ from a dispensing period in someembodiments. When used together, the run time of the portable nasalirrigator is the time measured from the first actuation of the portablenasal irrigator, while the dispensing period is the time interval thatthe user or administrator is allowed to use or actuate the portablenasal irrigator. Both the run time and the dispensing period, eitherindividually or together, may be predetermined or preset by themanufacturer, or programmed by a user and/or administrator of theportable nasal irrigator.

For example, in a default scenario, the user and/or administrator of theportable nasal irrigator may set up the airflow regulating system to runcontinuously for three minutes once an on/off button or switch is pushedor until the on/off button/switch is pushed again. The user and/oradministrator may also set up the airflow regulating system with splitdosage, so that the portable nasal irrigator runs for twenty seconds oruntil the on/off button is pushed for a total accumulated time of threeminutes with a thirty minute time span. The rationale for this splitdosage set up with an overall time span monitor is to ensure that theuser receives the full dosage within a time frame, and to prevent abuseof the portable nasal irrigator.

To further prevent abuse of the portable nasal irrigator, a lockoutperiod may be implemented in one embodiment. The user pushes the on/offbutton of the portable nasal irrigator, and the airflow regulatingsystem runs for twenty seconds or until the on/off button is pushed. Theairflow regulating system may monitor its run time toward the totalaccumulated time during an overall run time for delivery of irrigatorfluid. Once a total accumulated run time of three minutes is reachedwithin a thirty minute dispensing period, the airflow regulating systemdoes not deliver any more irrigator fluid until a lockout time periodpasses (6 hours, 12 hours, or 24 hours). Once the lockout time periodpasses, the airflow regulating system may then allow for the delivery ofirrigator fluid.

The airflow regulating system may limit the number of actuations so asto provide an escape for a user who has to stop the use of the portablenasal irrigator during the dispensing period. The airflow regulatingsystem monitors the number of dosages (or sub-dosages) delivered by theportable nasal irrigator, and calculates this monitored number towardsthe limited number of actuations. Sub-doses, also called sub-dosages,help improve absorption of the irrigator fluid and are portions of afull dosage, divided up.

This limitation of actuations may be used in conjunction with a lockoutperiod. A user or an administrator may set up the portable nasalirrigator to lock and prevent delivering any more of the irrigationfluid once the airflow regulating system determines that the maximumnumber of actuations has been reached. Alternatively, the user or anadministrator may set up the portable nasal irrigator to deliverfractions of a dosage of irrigation fluid over a longer period of timethan a full dosage requires, and the airflow regulating system maycompensate for this set up. The administrator of the portable nasalirrigator may program or set up the airflow regulating system forlimiting the number of actuations by directly connecting to the airflowregulating system or by other input/output connections, such as Wi-Fi,Bluetooth, Ethernet, etc.

In an exemplary embodiment, the airflow regulating system may permitdelivery for as long as the user requires actuation or delivery of theirrigator fluid. This embodiment of the airflow regulating system limitsthe number of actuations or deliveries of irrigator fluid. So, once auser presses the on/off button, irrigator fluid is dispensed via theportable nasal irrigator and will continue until the on/off button ispressed again. The user can continue to actuate the portable nasalirrigator until the limit of the number of actuations is reached. Oncethe actuation limit has been reached, the airflow regulating system mayprevent any more actuations for a lockout period (6, 12, or 24 hours).

In one embodiment of the portable nasal irrigator, the airflowregulating system may monitor and store patterns of use of the portablenasal irrigator. These patterns of use may be used by the user or theadministrator of the portable nasal irrigator, or by a healthcareprofessional, in determining whether the usage of the portable nasalirrigator is effective. The patterns of use may be transmitted from theprogrammable circuit board through its input/output ports to an externaldata collection device, which may comprise any computing device. Thetransmission may be across any communication channel, such as Wi-fi,BlueTooth, cellular, telephonic, cable, etc. The user or administrator,or healthcare professional, in turn, may program the airflow regulatingsystem to perform the above mentioned tasks, and the programmedinstructions may be stored in memory or any other tangiblenon-transitory computer useable medium.

FIGS. 37-42 illustrate one embodiment of an improved nasal drug deliverydevice. Generally, the improved nasal drug delivery device comprises acanister or main canister as described in any of the above embodiments,the canister comprising a puncturing element within its reservoir, aninsert as described in any of the above embodiments, a pressurized airsupply source as described in any of the above embodiments.

FIG. 37 is a cross section view of a portion of a canister according toone embodiment. The nasal drug delivery device comprises a canister 500comprising a reservoir, an air exit port 501 extending beyond a rim ofthe canister 500 and a puncturing element 502 on an inner surface 506 ofthe canister. In one embodiment, further described below, the nasal drugdelivery device comprises an extension between the fluid channel and thecanister, and a storage compartment comprising a filling, the storagecompartment attached to the extension, wherein at least a portion of thestorage compartment is formed of a material that can be penetrated bythe puncturing element to release the filling into the canister and forma medicated liquid prior to dispensing of a medicated mist through anexit hole of the fluid channel directly to a user. In anotherembodiment, the storage compartment is a separate and individual piece,unattached from, but for use in combination with, the improved device.

In some embodiments, the canister may comprise any of the abovedescribed canisters or main canisters; for example, as described withregard to FIGS. 1-17, 19A-27, and/or 29-31. In some embodiments, theinsert may comprise any of the above insert embodiments; for example, asdescribed with regard to FIGS. 1-17, and/or 19A-31. In one embodiment,the extension may comprise any of the above embodiments beginning atFIG. 12; for example, as shown in FIGS. 12-14, and 19A-30.

Turning to FIG. 37, the puncturing element 502 comprises a tip 504 thatis capable of piercing at least a portion of a storage compartment, asdescribed below. In one embodiment, the tip is curved. In oneembodiment, the tip is C-shaped. In one embodiment, the tip is J-shaped.In one embodiment, the puncturing element 502 is substantially vertical.However, angled puncturing elements 502 are also within the purview ofone skilled in the art, having read this disclosure. In one embodiment,one end of the puncturing element 502 is bonded, attached, or molded toan inner surface 506 of the canister. To accommodate for the insert ofthe device, the puncturing element 502 should be attached on an innersurface 506 outside a surface in which the foot or base of the insertfits. That is, the pointed end or tip 504 is located outside of the areaof the foot of the insert when placed within the canister. In oneembodiment, the opposite, pointed end 504 of the puncturing element iscontained within the reservoir; that is, the length of the puncturingelement is such that the puncturing tip is below the rim and does notextend above the rim. The length of the puncturing element 502 maytherefore vary in some embodiments. As described above, the canister maybe manufacture or formed by any means known in the art including withoutlimitation molding, forming, shaping or any combination thereof. Thus,the puncturing element 502 and the tip 504 may be molded within thereservoir as part of the canister in one integral piece in oneembodiment. In one embodiment, the reservoir may comprise a medicationable to be expelled through the device as a mist as described in any ofthe above embodiments.

FIG. 38 is a cross section view of an insert 515 in accordance with oneembodiment. In one embodiment, the nasal drug delivery device comprisesan extension 508 between an exterior portion of the fluid channel 509and the rim of the canister 500. In one embodiment, the extension 508extends from the insert to the rim. That is, the insert comprises theextension in one embodiment. In one embodiment, the extension 508extends from the fluid channel 509 to the rim of the canister, asdescribed in above embodiments. In one embodiment, the extension 508comprises a parabolic shape. As shown in FIG. 38, the insert comprises astorage compartment 510 below the extension 508. In one embodiment, thestorage compartment 510 is detachably connected to a bottom surface ofthe extension 508. In one embodiment, the storage compartment 510 ispermanently affixed to a bottom surface of the extension 508. In oneembodiment, the storage compartment 510 comprises an accessible fillingport 512, which extends from a top surface of the extension 508 throughto the bottom surface of underside of the extension 508. The size of thefilling port may vary so long as it does not exceed the boundaries ofthe storage compartment. In one embodiment, the size is only largeenough to allow for medication to be inserted into the storagecompartment. One skilled in the art, armed with this disclosure, willrecognized that a needle, for example, may be used for the inserting ofthe filling. In one embodiment, the accessible filling port 512comprises a seal 514, which can be placed over the accessible fillingport 512 after the storage compartment is filled. In one embodiment, theseal 514 is a hermetic seal.

FIG. 39 shows a top view of an assembled canister and insert within thecanister, with a view of one shape possible for the storage compartment.The device also comprises an air vent 522. In some embodiments, the airvent is located on an exterior surface of an extension so that it mayreadily accessed and opened by a user. In some embodiments, thepuncturing tip 504 punctures both the storage compartment 510 and thevent 522 to allow the filling to escape the bottom of the storagecompartment, while allowing air to enter the storage compartment throughthe vent. In this case, the vent would be placed on a concave section ofthe extension where the upper surface of the extension is lower than thelength of the distance the insert is inserted into the canister to befully seated. Alternatively, the air vent may be punctured by asecondary spike inside the canister. The exact placement of an air ventcan be readily determined by one skilled in the art, having read thisdisclosure.

The storage compartment may comprise a filling in any form capable ofinsertion into the storage compartment for flowing into the reservoirdue to piercing by the puncturing element. In some embodiments, thefilling works in combination with a substance within the canister. Insome embodiments, the filling within the storage compartment may work incombination with a liquid or powder substance within the reservoir. Insome embodiments, the filling within the storage compartment is a drysolid such as powder or flakes. In such embodiments, the reservoir ofthe canister comprises a liquid substance adapted to substantiallydissolve the dry powder. For example, in some embodiments, the fillingwithin the storage compartment may comprise an excipient for a drug. Anexcipient may comprise a sugar such as mannitol or xylitol, poloxamers,and/or methylcellulose, and/or any other component that would enable adrug to go into a solution or suspension. In some embodiments, thefilling comprises a medication. In some embodiments, the filling maycomprise an active pharmaceutical agent in the form of a dry powder. Inone embodiment, the filling within the storage compartment is a liquid.In some embodiments, the filling within the storage compartmentcomprises a diluent. In some embodiments, the reservoir within thestorage compartment comprises a diluent. In some embodiments, thefilling within the storage compartment combines with the secondarysubstance within the reservoir of the canister upon puncturing to form asuspension.

FIG. 40 is a cross sectional view of an assembled device 520 wherein theinsert comprising an extension and an attached storage compartment isplaced within the canister, wherein the fluid channel is placed over theair exit port in one embodiment. As depicted in FIG. 40, the puncturingelement 502 pierces the storage compartment 510 with the puncturing tip504. In embodiments comprising an extension wherein the storagecompartment is attached to an underside or bottom surface of theextension, the piercing takes places upon assembly or insertion of theinsert into the canister. One skilled in the art, armed with thisdisclosure, will also recognize that the length of the puncturingelement 502 may be shorter with attachment to a button element thatwould cause the puncturing tip 504 to move up and through the storagecompartment 510. Upon piercing, the filling within the storagecompartment flows into the reservoir. The device may then be shaken ifnecessary to form a material capable of exiting the device as a mist.

FIG. 41 depicts a cross section view of another embodiment of anassembled device 520 with insert and canister, the device comprisingmore than one puncturing element 502. While omitted in the Figure forclarity, the insert may also comprise an attached storage compartment asdescribed above. In such embodiments, the shape of the storagecompartment may comprise a larger percentage of the interior of thereservoir. Alternatively, the device may also comprise more than onestorage compartment. For example, the device may comprise an equalnumber of storage compartments and puncturing elements such that eachstorage compartment has a corresponding puncturing element.

FIG. 42 depicts another embodiment of an assembled nasal drug deliverydevice for which an extension is absent. In such embodiments, a separatestorage compartment 516 may be pierced through manual insertion by auser to fill the reservoir with a medicating or irrigating solution.

Sample medications particularly useful in the improved nasal drugdelivery device may comprise any of: antibiotics including macrolidessuch as clarithromycin and azithromycin; glycopeptides such asvancomycin; aminoglycosides such as gentamicin or tobramycin;fluoroquinolones such as levofloxacin and ciprofloxacin; monoxycarbolicacids such as mupirocin; beta-lactams including cephalosporins such asceftriaxone and ceftazadine; carbapenems such as meropenem and imipenem;penicillins such as tazobactam; ureidopenicillins such as piperacillin;lincosamide such as clindamycin; corticosteroids includingglucocorticosteroids such as fluticasone proprionate, budesonide,mometasone fuorate, betamethasone, beclamethasone; anti-fungalsincluding macrolide antifungals such as ampohetericin B, nystatin, azoleantifungals including triazole antifungals such as fluconazole anditraconazole; leukotriene receptor antagonists such as montelukast;antihistamines such as levozeterizine and loratadine; andmethylxanthines such as theophylline.

The method of the nasal drug delivery device described herein maycomprise the steps of providing a canister comprising a reservoir, anair exit port and a puncturing element, the air exit port extendingbeyond a rim of the canister; providing an insert comprising a fluidchannel, an extension between the fluid channel and the canister, and astorage compartment, wherein the fluid channel fits over the air exitport to provide a small space between an outer surface of the air exitport and an inner surface of the fluid channel; and inserting a fillinginto the storage compartment and a substance into the reservoir, suchthat a medication (or medication mixture in some embodiments) is createdwhen the filling and substance are combined and/or mixed together. Inone embodiment, the filling is a medication. In one embodiment, thesubstance is a medication. In one embodiment, the filling is a drysolid. In one embodiment, the substance is a dry solid. In variousembodiments, the dry solid is a powder. The dry solid may comprise anactive pharmaceutical agent. In one embodiment, the substance is asolution. In one embodiment, the substance is a diluent. In oneembodiment, the filling is a solution.

In one embodiment, the method further comprises the step of sealing thestorage compartment after the inserting step. In such embodiments, sealmay comprise a hermetic seal. In one embodiment, the method furthercomprises the step of attaching the storage compartment to the insertprior to the inserting of the filling. In one embodiment, the storagecompartment is attached to an extension of the insert. In oneembodiment, the storage compartment is detachable or separate. In oneembodiment, the method comprises the step of sealing together thecanister and the insert. Such embodiment may comprise a permanent seal.

In one embodiment, the inserting step comprises inserting a fillingthrough a filling port. The filling port provides access to thereservoir of the canister in some embodiments. In one embodiment, thecanister comprises the filling port. In one embodiment, the insertcomprises the filling port.

A number of benefits exist with the use of the aforementioned improvedembodiments. By using a dry powder as the filling within the reservoir,and a liquid substance within the storage compartment, for example, adry powder medication can be used within the reservoir and a salinesolution within the storage compartment can dissolve the dry powder intoa medication that can be dispensed to the user as a mist. By sealing theinsert and the canister, the shelf life is thus limited only to that ofthe saline or the shortest use before date for the medication. Withproper testing of a saline solution, the medication may comprise anextended shelf life of one to two years.

The invention illustratively disclosed herein suitably may be practicedin the absence of any element, which is not specifically disclosedherein. It should also be noted that the invention is not limited tohuman use, but may also be used with any number of mammals includingwithout limitation equine, canine, feline, non-human primate, rodent,bovine, ovine, and porcine.

The description of the present invention has been presented for purposesof illustration and description, and is not intended to be exhaustive orlimited to the invention in the form disclosed. Many modifications andvariations will be apparent to those of ordinary skill in the art. Theembodiment was chosen and described in order to best explain theprinciples of the invention, the practical application, and to enableothers of ordinary skill in the art to understand the invention forvarious embodiments with various modifications as are suited to theparticular use contemplated. It will be understood by one of ordinaryskill in the art that numerous variations will be possible to thedisclosed embodiments without going outside the scope of the inventionas disclosed in the claims.

1-36. (canceled)
 37. An interface for a nasal drug delivery devicecomprising: a canister comprising a reservoir, an air exit port and apuncturing element on an inner surface of the canister, wherein the airexit port extends beyond a rim of the canister and the puncturingelement comprising a puncturing tip positioned below the rim; an insertcomprising a fluid channel that fits over the air exit port; and whereinthe air exit port defines and end of a tube portion extending from apressurized air supply source interface at an opposite end of the tubeportion from the air exit port, the air supply source interfaceconfigured for receiving pressurized air from a pressurized air supplysource and directing pressurized air through the air exit port todispense a medication within the reservoir in the form of a mist. 38.The interface of claim 35 comprising an extension between the fluidchannel and the canister, and a storage compartment comprising afilling, the storage compartment attached to the extension and theextension comprising an air vent on the storage compartment, wherein atleast a portion of the storage compartment is formed of a material thatcan be penetrated by the puncturing element to release the filling intothe canister to provide for the medication to be dispensed through anexit hole of the fluid channel directly to a user.
 39. The interface ofclaim 35 wherein the medication is derived at least in part from aseparate, detached storage compartment, said detached storagecompartment pierceable by the puncturing tip to provide for filling thereservoir with the medication due to piercing.
 40. The interface ofclaim 37 wherein the reservoir comprises a powder.
 41. The interface ofclaim 40 wherein the storage compartment comprises a liquid capable ofsubstantially dissolving the powder.
 42. The interface of claim 38wherein the filling comprises a liquid.
 43. The interface of claim 38wherein the storage compartment is permanently attached to theextension.
 44. The interface of claim 38 wherein the storage compartmentis detachable.
 45. The interface of claim 38 wherein the storagecompartment comprises an accessible filling port.
 46. The interface ofclaim 38 wherein the storage compartment comprises a hermetic seal. 47.The interface of claim 37 wherein the canister and the insert are sealedtogether.
 48. The interface of claim 37 comprising more than one storagecompartment.
 49. The interface of claim 37 comprising more than onepuncturing element.
 50. The interface of claim 37 wherein the fluidchannel fits over the air exit port to provide a small space between anouter surface of the air exit port and an inner surface of the fluidchannel.
 51. The interface of claim 38 wherein the fluid channelcomprises a groove extending vertically along the exterior of the fluidchannel to an aperture in the extension, said aperture creating achannel to the reservoir of the canister.
 52. The interface of claim 37wherein the medication comprises an antibiotic.
 53. The interface ofclaim 37 wherein the medication comprises a glycopeptide antibiotic. 54.The interface of claim 53 wherein the medication comprises glycopeptidevancomycin.
 55. The interface of claim 37 wherein the medicationcomprises a corticosteroid.
 56. The interface of claim 37 wherein themedication comprises an anti-fungal.